NCT07927595 Observational Connectomics in Adults Undergoing Resection of WHO II-IV Glioma
| NCT ID | NCT07927595 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Glioma |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2026-02-01 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 informed consent. 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: 1. Juvenile pilocytic glioma (WHO I) 2. Histology that is non-glioma, e.g., brain metastases, craniopharyngioma, ependymoma, medulloblastoma, meningioma, lymphoma, tumefactive (demyelinative) plaque, abscess, germinoma, arachnoid cyst, epidermoid, PXA, DNET, ganglioglioma, central neurocytoma, 3. Inability to give informed consent. 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 contraceptive 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. KPS \< 40. 12. Age \< 17.
Contact & Investigator
Randy D'Amico, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT07927595 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07927595 currently recruiting?
Yes, NCT07927595 is actively recruiting participants. Contact the research team at rdamico8@northwell.edu for enrollment information.
Where is the NCT07927595 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07927595 clinical trial?
NCT07927595 is sponsored by Northwell Health. The principal investigator is Randy D'Amico, MD at Northwell Health. The trial plans to enroll 125 participants.