ClinicalTrials.gg
RecruitingNCT06605404Updated Sep 24, 2026

Pan-tumor MRD Study

An observational study in Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer and Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, sponsored by Paradigm Health. Recruiting at 47 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Paradigm Health · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,350
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 675 studies in Esophageal Neoplasms with a site in United States — 121 open to participants now, 171 under way, 2 of them phase 3. Esophageal Neoplasms · United States.

Planned enrollment
25th of 111
1,350 · median 159
Started
2025
with 27 others
Observational
111 of 675
33 open now
Primary completion
2031-12
later than 162 of 169 live
Registered
627th of 675
by date

Among the 675 studies in Esophageal Neoplasms with a site in United States, this one is the 25th largest by planned enrollment of the 111 observational ones that give a count, is one of 28 that started in 2025, is one of 111 observational ones, reaches primary completion later than 162 of the 169 other live ones, and was the 627th registered.

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

Browse Esophageal Neoplasms studies →

Open to participants now

121 of the 675 studies in Esophageal Neoplasms with a site in United States are open now. Recruiting first, the newest first:

116 more — sign in →

All 121 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 675 studies in Esophageal Neoplasms with a site in United States, or all of them as a file.
02

Study summary

The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.

Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.

03

Conditions studied

  • Muscle Invasive Bladder Urothelial Carcinoma
  • Esophageal Cancer
  • Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Melanoma (Skin Cancer)
  • NSCLC (Non-small Cell Lung Cancer)
  • Pancreatic (Exocrine Only)
  • Mix of Solid Tumors (MOST)

Keywords

  • observational
  • biospecimen
  • routine care
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors

Eligibility criteria

Eligibility Criteria:

  1. Age 18 years or older.
  2. Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1).
  3. Eligible for curative intent therapy, with surgical resection of cancer planned.

    a. If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of therapy.

  4. (ECOG) performance status (PS) of 0, 1, or 2.
  5. No systemic therapy for current cancer diagnosis administered before enrollment.
  6. Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic or surgical excision.
  7. Has completed all therapy (including endocrine therapy) 3 or more years ago for any previous invasive solid organ (with exception of nonmelanoma skin cancers) or hematologic malignancy. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment (no required).
  8. No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.
  9. No prior hematopoietic stem cell transplant.
  10. Able and willing to provide and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information.

    Cohort Specific Criteria

  11. Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:
  12. Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.
  13. Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.
  14. MOST cohort: Stage II or operable stage III solid tumor diagnosis that meets eligibility criteria and is not included in the other cohorts.

The following tumor types are excluded:

  1. Central nervous system (CNS) malignancies
  2. Colorectal cancer
  3. Breast cancer
  4. Squamous cell skin cancer
  5. Basal cell carcinoma
  6. Gastrointestinal stromal tumors (GIST)
  7. Thyroid cancer
  8. Uveal melanoma
  9. Low or intermediate grade neuroendocrine tumors

    ■ Eligible tumor types: High-grade neuroendocrine tumors, including neuroendocrine carcinomas, Merkel cell carcinomas, and small cell lung cancer are permissible

  10. Hematologic cancers including multiple myeloma or other plasma cell dyscrasias, Hodgkin\'s lymphoma, non-Hodgkin\'s lymphoma, acute or chronic leukemias including chronic lymphocytic leukemia / small lymphocytic leukemia
Terms in these criteria, in plain language(7)

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.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,350 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

    Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)

    Diagnostic Test: blood and tissue samples · Other: blood and tissue samples

  • Esophageal

    Esophageal cancer

    Diagnostic Test: blood and tissue samples · Other: blood and tissue samples

  • Gastric and Gastroesophageal Junction (GEJ)

    Gastric and Gastroesophageal Junction (GEJ)

    Diagnostic Test: blood and tissue samples · Other: blood and tissue samples

  • Melanoma

    Melanoma

    Diagnostic Test: blood and tissue samples · Other: blood and tissue samples

  • Non-small cell lung (NSCLC)

    Non-small cell lung (NSCLC)

    Diagnostic Test: blood and tissue samples · Other: blood and tissue samples

  • Pancreatic (exocrine only)

    Pancreatic (exocrine only)

    Diagnostic Test: blood and tissue samples · Other: blood and tissue samples

  • Mix of Solid Tumors (MOST)

    Mix of Solid Tumors (MOST)

    Diagnostic Test: blood and tissue samples · Other: blood and tissue samples

Interventions

  • Diagnostic testblood and tissue samples

    routine standard of care

  • Otherblood and tissue samples

    Routine standard of care

06

What researchers measure

Primary outcomes

  1. Blood and tissue biospecimen registry

    To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.

    Time frame: Observation from enrollment to 5.5 years after enrollment

07

Study locations

47 of 47 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Dec 2031, 83 months after the start.

Of 174 observational studies under Esophageal Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 252. This study's planned 83 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2024
First posted
Sep 20, 2024
StartActual
Jan 8, 2025
Primary completionEst.
Dec 2031
CompletionEst.
Apr 2032
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06605404
Lead sponsor
Paradigm Health
Responsible party
Sponsor
First posted
Sep 20, 2024
Start date
Jan 8, 2025
Primary completion
Dec 2031 (estimated)
Completion
Apr 2032 (estimated)
Last update
Sep 24, 2026

Study contacts

Anosheh Afghahi, MD
Contact
anosheh.afghahi@paradigmhealth.ai
888-662-6367

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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