ClinicalTrials.gg
RecruitingNCT07927595Updated Nov 10, 2026

Observational Connectomics in Adults Undergoing Resection of WHO II-IV Glioma

An observational study in Glioma, Glioma (Any Grade) in the Brain and Glioblastom WHO Grade 4, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Primary conditionGlioblastomaRegistry: GliomaReclassifiedWhy we changed it
Registry
Glioma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Glioblastoma
Why
  1. The study's listed conditions name Glioblastoma, a narrower term within Glioma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Northwell Health · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
All
01

Study summary

This observational study will create a large scale database (registry) of glioma patients' data across multiple participating institutions (hospitals) to study a range of clinical research questions.

Read the detailed description

The Glioma Connectome Project (GCP) is a study that seeks to use safe, powerful, non-invasive computing tools of machine learning and artificial intelligence, to take information from the functional MRI resting state (rs-fMRI) and the anatomic MRI using diffusion-weighted MRI to develop a comprehensive map of the brain. This "Virtual Brain" in the future may assist neurosurgeons in planning glioma surgery, understanding the cause of neurological deficits caused by the tumor, and a road map to help avert postoperative deficits, while also monitoring recovery of neurological function, as the brain "heals" or reorganizes itself through neuroplasticity.

The information from your MRI will be analyzed using algorithms to produce a map of the key tracts, functional hubs, and connections in the brain in terms of seven major networks: sensorimotor, visual, central executive (CEN), default mode (DMN), salience, dorsal attention (DAN) and limbic system. The completion of the project will advance diagnostics, brain imaging, brain tumor surgery, and provide the basis for new tools and drugs to treat brain injury and accelerate recovery of neurological function lost to the tumor, and treatments for the tumor, including surgery, radiation, chemotherapy.

The registry is being created to evaluate new computer-based technology that builds on ourknowledge of the human brain through the Glioma Connectome Project, which discovered that the brain could be divided into 180 areas per hemisphere or "parcellations", each with a function that is achieved by signaling other areas, forming broad networks, which influence brain function and brain health. Seven major networks are of great interest as they influence human neurological performance. These networks will be identified in the current study, throughout the course of the treatment for your glioma, by using the advanced neuroimaging which is standard of care at Lenox Hill Hospital.

02

Conditions studied

  • Glioma
  • Glioma (Any Grade) in the Brain
  • Glioblastom WHO Grade 4
  • Glioblastoma
  • Glioblastoma (GBM)
  • Grade III Astrocytoma
  • Grade II Glioma
  • Grade IV Astrocytoma
  • Grade IV Glioma
  • Grade III Glioma

Browse trials for

Keywords

  • Connectome
  • Observational
03

In context

Glioblastoma Reclassified

2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.

This study's planned enrollment of 125 is above the median of 60 across 208 observational studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.

Compared within Glioblastoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Glioma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

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

Study population

Newly diagnosed and recurrent glioma (WHO grade II, III, IV) undergoing surgery

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

  1. Age > 18 years.
  2. Newly diagnosed patients (by MRI) suspected of having a brain tumor (WHO II,III, or IV) who will undergo surgery with histological confirmation or patients undergoing surgery for recurrent brain tumor (WHO grades II, III, IV) whose histology confirms glioma and/or treatment effect.
  3. Diffuse astrocytomas, multifocal gliomas, oligodendrogliomas, midline and brainstem gliomas are included.
  4. Previously treated (progressive, recurrent) gliomas are included. Thus, prior surgery, radiation therapy, anti-angiogenic therapy, electrical field therapy are not exclusions.
  5. Patient must be able to give . S/he must be able to read and understand English or there must be a qualified interpreter.
  6. Must be able to undergo sequential MRI in a facility that can perform 30-directional MRI for connectomic analyses.

Exclusion criteria

Exclusion Criteria:

  1. Juvenile pilocytic glioma (WHO I)
  2. Histology that is non-glioma, e.g., , craniopharyngioma, ependymoma, medulloblastoma, meningioma, lymphoma, tumefactive (demyelinative) plaque, abscess, germinoma, arachnoid cyst, epidermoid, PXA, DNET, ganglioglioma, central neurocytoma,
  3. Inability to give .
  4. Tissue samples obtained at surgery are insufficient/ or non-diagnostic for glioma
  5. Expected survival \< 90 days due to primary disease or medical co-morbidities. (e.g. sepsis, pneumonia, organ failure)
  6. Inability to have a MRI due to cardiac pacemaker, implants, claustrophobia, allergy to gadolinium,
  7. Pregnancy. Because of potential risk of serial MRI to fetus, women of child-bearing age will need a pregnancy test and agree to practices during the course of the study.
  8. Vulnerable population
  9. Medications. There are no restrictions on medications. Patients will receive best standard of care.
  10. Clinical Trials. Patients may also be enrolled in a clinical trial as a clinical trial is always recommended for patients with a glioma per NCCN guidelines.
  11. \< 40.
  12. Age \< 17.
Terms in these criteria, in plain language(4)

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.

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.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (estimated)
Patient registry
No

Groups and cohorts

  • Newly diagnosed or recurrent glioma (WH) II, III, or IV)

    Newly diagnosed patients (by MRI) suspected of having a glioma (WHO II,III, or IV) who will undergo surgery with histological confirmation or patients undergoing surgery for recurrent glioma (WHO grades II, III, IV) whose histology confirms glioma and/or treatment effect.

    Other: Connectome MRI · Other: Neuropsychological testing

Interventions

  • OtherConnectome MRI

    Advanced MRI imaging done preoperatively, immediately following surgery, one month after surgery, and 3 months after surgery, then every 2 to 3 months for the duration of the study. These images are being done as standard of care and include functional MRI resting state (rs-fMRI) and the anatomic MRI using diffusion-weighted MRI to develop a comprehensive map of the brain.

    Also known as: MRI

  • OtherNeuropsychological testing

    Neuropsychological test that will be administered on an iPad, and should take no more than one hour to complete. Subjects will first complete a mini mental state exam to assess their mental status. This will only take 5-10 minutes to complete. Based on the results they may undergo all or some of the following neuropsychological tests which will be completed on an iPad: * Reaction Time * Rapid Visual Information Processing * Paired Associates Learning Delayed Matching to Sample * Verbal Recognition Memory * Multitasking Test * Spatial Working Memory * Emotion Recognition Task

    Also known as: Cambridge Cognition, Mini Mental State Exam

06

What researchers measure

Primary outcomes

  1. Connectomic Metrics

    FWHM (Full width-Half maximum)

    Time frame: From enrollment up to 5 years.

  2. Connectomic Metrics

    Network index

    Time frame: From enrollment up to 5 years.

  3. Connectomic Metrics

    Betweenness centrality (the value of each node to the whole network, defined by the fraction of the shortest paths passing through this node to all shortest paths that do not pass through it)

    Time frame: From enrollment up to 5 years.

Secondary outcomes

  1. KPS

    The KPS describes a patient's functional status as a comprehensive 11-point scale correlating to percentage values ranging from 100% (no evidence of disease, no symptoms) to 0% (death). Each percentage reflects the patient's ability to perform daily activities and their level of independence or care needs. For instance, 100% indicates full independence, while 10% describes a moribund state with rapid disease progression.

    Time frame: From enrollment up to 5 years.

  2. Progression-free survival

    Progression-free survival (PFS) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease without it getting worse, growing, or spreading

    Time frame: From enrollment up to 5 years.

  3. Overall survival (OS)

    Overall survival (OS) is the length of time from either the date of diagnosis or the start of a treatment until death from any cause.

    Time frame: From enrollment up to 5 years.

  4. Molecular markers and drivers of glioma growth

    IDH mutational status, MGMT, ki-67, EGFR, p53, ATRX, TERT promoter, 1p19q chromosomal deletions, extent of resection, length of hospital stay

    Time frame: From enrollment up to 5 years.

07

Study locations

1 of 1 sites recruiting
  • Lenox Hill Brain Tumor Center
    New York, New York 10075, United States
    Recruiting
    • Randy D'Amico, MD · Contactrdamico8@northwell.edu · 212-434-3900
    • Tamik Wong, MPH · Contacttwong4@northwell.edu · 212-434-4836
    • Randy D'Amico, MD · Principal investigator
    • Tamika Wong, MPH · Sub investigator
    • John Boockvar, MD · Sub investigator
    • Netanel Ben-Shalom, MD, FNPS · Sub investigator
    • David Langer, MD · Sub investigator
    • Taylor Winby, NP · Sub investigator
    • Olivia Albers, NP · Sub investigator
    • Elizabeth Lepski, NP · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — Clinical Data from the other study centers part of the Glioma Connectome Project (GCP) will be transferred pseudonymously.

No publications or documents are linked to this record.

09

Timeline

1 registry update 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 Feb 2026 (actual). Primary completion is estimated for Feb 2028, 24 months after the start.

Of 84 non-industry observational studies under Glioblastoma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 96. This study's planned 24 months is below that.

Counting every sponsor, half of 99 studies reached it within 52 months; a quarter within 33 and three quarters within 96.

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

Registered
Aug 25, 2026
First posted
Nov 10, 2026
StartActual
Feb 1, 2026
Primary completionEst.
Feb 2028
CompletionEst.
Feb 2033
Last update
Nov 10, 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.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927595
Lead sponsor
Northwell Health
Collaborators
StacheStrong
Responsible party
Sponsor
First posted
Nov 10, 2026
Start date
Feb 1, 2026
Primary completion
Feb 2028 (estimated)
Completion
Feb 2033 (estimated)
Last update
Nov 10, 2026

Study contacts

Randy D'Amico, MD
Contact
rdamico8@northwell.edu
212-434-3900
Tamika Wong, MPH
Contact
twong4@northwell.edu
212-434-4836
Randy D'Amico, MD
principal investigator · Northwell Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion