Molecular-Guided Therapy for Childhood Cancer (NCT02162732)

01

Study summary

The purpose of this study is to test the feasibility (ability to be done) of experimental technologies to determine a tumor's molecular makeup. This technology includes a genomic report based on DNA exomes and RNA sequencing that will be used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future.

02

Conditions studied

Neuroblastoma
Medulloblastoma
Glioma
Ependymoma
Choroid Plexus Neoplasms
Craniopharyngioma
Dysembryoplastic Neuroepithelial Tumor
Meningioma
Primitive Neuroectodermal Tumors (PNETs)
Germ Cell Tumors
Rhabdomyosarcoma
Non-rhabdomyosarcoma
Ewings Sarcoma
Osteosarcoma
Wilms Tumor
Renal Cell Carcinoma
Malignant Rhabdoid Tumor
Clear Cell Sarcoma
Liver Tumors

Browse trials for

03

In context

Neuroblastoma

675 studies on the registry are indexed under Neuroblastoma; 127 are open to participants now.

This study's enrollment of 186 is above the median of 32 across 507 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Giselle Sholler is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 13 Months to 21 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is to established proven therapies fitting into one of the following categories:
- Neuroblastoma- Patients that have relapsed following standard of care therapy (such as high risk patients, patient presenting after age 15 months or MYCN amplified, and only following (for eligible patients) high-dose chemotherapy followed by hematopoietic stem cell transplantation and maintenance therapy with retinoic acid and antibody therapy) or having progressed during standard of care therapy and non-responsive/progressive to accepted curative chemotherapy.
- Brain Tumors
- Medulloblastomas (At relapse after standard of care therapy [surgery, chemotherapy and/or radiation] and/or non-responsive/progressive on accepted curative therapy)
- Gliomas (At relapse after standard of care therapy [surgery and/or radiation and/or chemotherapy] and/or non-responsive/progressive on accepted curative therapy)
- Ependymomas (At relapse after standard of care therapy [surgery with or without radiation] and/or non-responsive/progressive on accepted curative therapy)
- Choroid plexus tumors (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)
- Craniopharyngiomas (At relapse after standard of care therapy [surgery or suppressive therapy] and/or non-responsive/progressive on accepted curative therapy)
- Dysembryoplastic neuroepithelial tumors (DNETs) (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)
- Meningiomas (At relapse after standard of care therapy [surgery] and/or non-responsive/progressive on accepted curative therapy)
- Primitive Neuroectodermal Tumors (PNETs) (At relapse after standard of care therapy [surgery, chemotherapy, and/or radiation] and/or non-responsive/progressive on accepted curative therapy)
- Germ cell tumors (At relapse after standard of care therapy [surgery, and/or radiation and/or chemotherapy] and/or non-responsive/progressive on accepted curative therapy)
- Rare Tumors:
- Soft tissue sarcoma Rhabdomyosarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy) Non-rhabdomyosarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy)
- Bone Ewings sarcoma (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Osteosarcoma (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy)
- Renal Wilms tumor (At relapse after standard of care therapy [surgery, and/or radiation, chemotherapy] and/or non- responsive/progressive to accepted chemotherapy) Renal cell carcinoma (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Malignant rhabdoid tumor (At diagnosis, as there is no known curative therapy) Clear Cell Sarcoma- (At relapse after standard of care therapy [radiation, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy) Germ Cell tumors (At relapse after standard of care therapy [surgery, chemotherapy] and/or non-responsive/progressive to accepted curative chemotherapy)
- Liver Tumors (At relapse after standard of care therapy [surgery, chemotherapy] and/or non- responsive/progressive to accepted curative chemotherapy)
Subjects must be age >12 months at enrollment
Subjects must be age ≤ 21 years at initial diagnosis
Subjects must have as demonstrated by residual abnormal tissue at a primary or site (measurable on CT or MRI) at the time of ; tumor must be accessible for biopsy. In addition, subjects with bone or bone marrow only disease expected to be >75% tumor are eligible to enroll.
Current disease state must be one for which there is currently no known effective therapy
Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of testing.
Lansky or Score must be ≥ 50
Subjects without bone marrow metastases must have an > 750/μl to begin treatment.
Subjects with CNS disease must have been on a stable dose of for 2 weeks prior to their biopsy and must not have progressive hydrocephalus at enrollment.
Adequate liver function must be demonstrated, defined as:
- Total ≤ 1.5 x (ULN) for age AND
- (SGPT) \< 10 x upper limit of normal (ULN) for age
A negative serum pregnancy test is required for female participants of child bearing potential (≥13 years of age or after onset of menses)
Both male and female post-pubertal study subjects need to agree to use one of the more effective methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines

Exclusion criteria

Exclusion Criteria:

Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to
Subjects who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy).
Subjects receiving any drug concurrently.
Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor)
Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the , and subject's ability to cooperate and participate in the study

Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 186 participants (actual)

Study arms

Experimental
Guided Therapy
A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
Device: Guided Therapy

Interventions

DeviceGuided Therapy
A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).

06

What researchers measure

Primary outcomes

Days to Treatment Will be Used in Order to Determine Feasibility of Using Tumor Samples to Assess Genomic Sequencing Using Predictive Modeling to Make Real-time Treatment Decisions for Children With Relapsed/Refractory Cancers.
The definition of feasibility is: Enrollment onto study, genomic profile, analysis and report generation completed, tumor board held with treatment decision, treatment review completed, start of treatment, and completion of 1 cycle of therapy.
Time frame: 2 years

Secondary outcomes

Number of Participants With an Unexpected Adverse Events as a Measure of Safety
To determine the safety of allowing a molecular tumor board to determine individualized treatment plans
Time frame: Adverse Events were collected starting with the date of the first dose of study drug until 30 days after last dose of study drug, ongoing related adverse events were continued to be followed until resolution, on average of 4 years.
Overall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.
To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria. The assessment of response will include the initial measurable targets and will be performed after cycle 2, then after every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI imaging and/or by MIBG or PET scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, At least a 20% increase in the sum of the disease measurements for measurable lesions, Stable Disease, Neither sufficient decrease to qualify for PR or sufficient increase to qualify for PD from study entry. Overall Response (OR) = CR + PR.
Time frame: Followed until off therapy, generally 4 years
Progression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.
Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment (nadir), and minimum 5 mm increase over the nadir or the appearance of one or more new lesions or appearance of positive bone marrow.
Time frame: From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years

07

Results

Posted Apr 5, 2024

Participant flow

Participant flow — Overall Study
Milestone	Guided Therapy
Started	186
Completed	168
Not completed	18
Withdrew: Biopsy not performed.	18

Outcome measures

PrimaryDays to Treatment Will be Used in Order to Determine Feasibility of Using Tumor Samples to Assess Genomic Sequencing Using Predictive Modeling to Make Real-time Treatment Decisions for Children With Relapsed/Refractory Cancers.

The definition of feasibility is: Enrollment onto study, genomic profile, analysis and report generation completed, tumor board held with treatment decision, treatment review completed, start of treatment, and completion of 1 cycle of therapy.

Time frame:: 2 years
Reported as:: Mean · Days

Days to Treatment Will be Used in Order to Determine Feasibility of Using Tumor Samples to Assess Genomic Sequencing Using Predictive Modeling to Make Real-time Treatment Decisions for Children With Relapsed/Refractory Cancers.
Days	Neuroblastoma	CNS Tumors	Rare Tumors
Days to Treatment Will be Used in Order to Determine Feasibility of Using Tumor Samples to Assess Genomic Sequencing Using Predictive Modeling to Make Real-time Treatment Decisions for Children With Relapsed/Refractory Cancers.	31 (18 to 75)	48 (18 to 146)	35 (20 to 98)

SecondaryNumber of Participants With an Unexpected Adverse Events as a Measure of Safety

To determine the safety of allowing a molecular tumor board to determine individualized treatment plans

Time frame:: Adverse Events were collected starting with the date of the first dose of study drug until 30 days after last dose of study drug, ongoing related adverse events were continued to be followed until resolution, on average of 4 years.
Reported as:: Count of participants · Participants

Number of Participants With an Unexpected Adverse Events as a Measure of Safety
Participants	Guided Therapy
Number of Participants With an Unexpected Adverse Events as a Measure of Safety	6

SecondaryOverall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.

To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria. The assessment of response will include the initial measurable targets and will be performed after cycle 2, then after every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI imaging and/or by MIBG or PET scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, At least a 20% increase in the sum of the disease measurements for measurable lesions, Stable Disease, Neither sufficient decrease to qualify for PR or sufficient increase to qualify for PD from study entry. Overall Response (OR) = CR + PR.

Time frame:: Followed until off therapy, generally 4 years
Reported as:: Count of participants · Participants

Overall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.
Participants	Neuroblastoma	CNS Tumors	Rare Tumors
Complete Response	4	2	5
No Evidence of Disease	1	11	6
Partial Response	0	4	7
Stable Disease	13	10	18
Progressive Disease	9	10	24

SecondaryProgression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.

Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment (nadir), and minimum 5 mm increase over the nadir or the appearance of one or more new lesions or appearance of positive bone marrow.

Time frame:: From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years
Reported as:: Mean · Days

Progression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.
Days	Neuroblastoma	CNS Tumors	Rare Tumors
Progression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.	153 (45 to 556)	283 (50 to 1415)	163 (28 to 1317)

Adverse events

Collected over Adverse Events were collected starting with the date of the first dose of study drug until 30 days after last dose of study drug, ongoing related adverse events were continued to be followed until resolution, on average of 4 years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Guided Therapy	3/144 (2.1%)	0/144 (0%)	6/144 (4.2%)

Most frequent other events

Most frequent other events
Event	Guided Therapy
InfectionInfections and infestations	2/144
LeukopeniaBlood and lymphatic system disorders	1/144
Alanine Transaminase increasedHepatobiliary disorders	1/144
Aspartate TransferaseHepatobiliary disorders	1/144
DehydrationMetabolism and nutrition disorders	1/144
Oral MucositisGastrointestinal disorders	1/144
PancreatitisHepatobiliary disorders	1/144

Baseline characteristics

Subjects that started at least one dose of study therapy

Age, Categorical
Age, Categorical(Participants)	Guided Therapy
<=18 years	134
Between 18 and 65 years	10
>=65 years	0

Age, Continuous
Age, Continuous(years)	Guided Therapy
Mean	11.04 (1 to 23)

Sex: Female, Male
Sex: Female, Male(Participants)	Guided Therapy
Female	62
Male	82

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Guided Therapy
Hispanic or Latino	13
Not Hispanic or Latino	108
Unknown or Not Reported	23

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Guided Therapy
American Indian or Alaska Native	0
Asian	5
Native Hawaiian or Other Pacific Islander	0
Black or African American	10
White	93
More than one race	0
Unknown or Not Reported	36

Tumor Type
Tumor Type(Participants)	Guided Therapy
Neuroblastoma	31
CNS Tumor	41
Rare Tumor	72

08

Study locations

19 sites

Arkansas Children's Hospital
Little Rock, Arkansas 72202, United States
Rady Children's Hospital
San Diego, California 92123, United States
Connecticut Children's Hospital
Hartford, Connecticut 06106, United States
Arnold Palmer Hospital for Children
Orlando, Florida 32806, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96813, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503, United States
Children's Hospital and Clinics on Minnesota
Minneapolis, Minnesota 55404, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri 63104, United States
The Children's Hospital at Montefiore
The Bronx, New York 10467, United States
Levine Children's Hospital
Charlotte, North Carolina 28204, United States
Randall Children's Hospital
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania 17033, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
Monroe Carrell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232, United States
Dell Children's Blood and Cancer Center
Austin, Texas 78723, United States
Texas Children's Cancer and Hematology Centers
Houston, Texas 77030, United States
Primary Children's Hospital
Salt Lake City, Utah 84113, United States
American University of Beirut Medical Center
Beirut, Lebanon

09

References and documents

Publications

Sholler GLS, Bergendahl G, Lewis EC, Kraveka J, Ferguson W, Nagulapally AB, Dykema K, Brown VI, Isakoff MS, Junewick J, Mitchell D, Rawwas J, Roberts W, Eslin D, Oesterheld J, Wada RK, Pastakia D, Harrod V, Ginn K, Saab R, Bielamowicz K, Glover J, Chang E, Hanna GK, Enriquez D, Izatt T, Halperin RF, Moore A, Byron SA, Hendricks WPD, Trent JM. Molecular-guided therapy for the treatment of patients with relapsed and refractory childhood cancers: a Beat Childhood Cancer Research Consortium trial. Genome Med. 2024 Feb 12;16(1):28. doi: 10.1186/s13073-024-01297-5. PubMed 38347552 ↗

Study documents

Protocol and statistical analysis plan ↗ · Jan 10, 2017
Informed consent form ↗ · Jan 10, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID: NCT02162732
Lead sponsor: Giselle Sholler
Collaborators: Translational Genomics Research Institute, Dell, Inc.
Responsible party: Giselle Sholler (Study Chair, Milton S. Hershey Medical Center) — Sponsor-investigator
First posted: Jun 13, 2014
Start date: Jul 8, 2014
Primary completion: Jan 18, 2024
Completion: Jan 18, 2024
Results posted: Apr 5, 2024
Last update: Nov 3, 2025

Study contacts

Giselle Sholler, MD

study chair · Beat Childhood Cancer at Atrium Health

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Molecular-Guided Therapy for Childhood Cancer

Study summary

Conditions studied

Browse trials for

In context

Neuroblastoma

Lead sponsor

Who can participate

Inclusion criteria

Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Related links

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Molecular-Guided Therapy for Childhood Cancer

Study summary

Conditions studied

Browse trials for

In context

Neuroblastoma

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Related links

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria