Observational Connectomics in Adults Undergoing Resection of WHO II-IV Glioma
A Prospective, Longitudinal, Multi-Institutional, Observational Study to Correlate Quantitative Changes of the Human Structural and Functional Connectome in Adults Undergoing Neurosurgical Resection of WHO II-IV Glioma
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Tamika Wong, MPH
- Numer telefonu: 212-434-4836
- E-mail: twong4@northwell.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Randy D'Amico, MD
- Numer telefonu: 212-434-3900
- E-mail: rdamico8@northwell.edu
Lokalizacje studiów
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New York
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New York, New York, Stany Zjednoczone, 10075
- Rekrutacyjny
- Lenox Hill Brain Tumor Center
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Pod-śledczy:
- David Langer, MD
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Pod-śledczy:
- Tamika Wong, MPH
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Główny śledczy:
- Randy D'Amico, MD
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Pod-śledczy:
- John Boockvar, MD
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Pod-śledczy:
- Olivia Albers, NP
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Kontakt:
- Randy D'Amico, MD
- Numer telefonu: 212-434-3900
- E-mail: rdamico8@northwell.edu
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Kontakt:
- Tamik Wong, MPH
- Numer telefonu: 212-434-4836
- E-mail: twong4@northwell.edu
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Pod-śledczy:
- Netanel Ben-Shalom, MD, FNPS
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Pod-śledczy:
- Taylor Winby, NP
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Pod-śledczy:
- Elizabeth Lepski, NP
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Newly diagnosed and recurrent glioma (WHO grade II, III, IV) undergoing surgery
Opis
Inclusion Criteria:
- Age > 18 years.
- 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.
- Diffuse astrocytomas, multifocal gliomas, oligodendrogliomas, midline and brainstem gliomas are included.
- Previously treated (progressive, recurrent) gliomas are included. Thus, prior surgery, radiation therapy, anti-angiogenic therapy, electrical field therapy are not exclusions.
- 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.
- Must be able to undergo sequential MRI in a facility that can perform 30-directional MRI for connectomic analyses.
Exclusion Criteria:
- Juvenile pilocytic glioma (WHO I)
- 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,
- Inability to give informed consent.
- Tissue samples obtained at surgery are insufficient/ or non-diagnostic for glioma
- Expected survival < 90 days due to primary disease or medical co-morbidities. (e.g. sepsis, pneumonia, organ failure)
- Inability to have a MRI due to cardiac pacemaker, implants, claustrophobia, allergy to gadolinium,
- 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.
- Vulnerable population
- Medications. There are no restrictions on medications. Patients will receive best standard of care.
- 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.
- KPS < 40.
- Age < 17.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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. |
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.
Inne nazwy:
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:
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Connectomic Metrics
Ramy czasowe: From enrollment up to 5 years.
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FWHM (Full width-Half maximum) |
From enrollment up to 5 years.
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Connectomic Metrics
Ramy czasowe: From enrollment up to 5 years.
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Network index |
From enrollment up to 5 years.
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Connectomic Metrics
Ramy czasowe: From enrollment up to 5 years.
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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) |
From enrollment up to 5 years.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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KPS
Ramy czasowe: From enrollment up to 5 years.
|
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. |
From enrollment up to 5 years.
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Progression-free survival
Ramy czasowe: From enrollment up to 5 years.
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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 |
From enrollment up to 5 years.
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Overall survival (OS)
Ramy czasowe: From enrollment up to 5 years.
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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. |
From enrollment up to 5 years.
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Molecular markers and drivers of glioma growth
Ramy czasowe: From enrollment up to 5 years.
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IDH mutational status, MGMT, ki-67, EGFR, p53, ATRX, TERT promoter, 1p19q chromosomal deletions, extent of resection, length of hospital stay |
From enrollment up to 5 years.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Randy D'Amico, MD, Northwell Health
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory
- Nowotwory według typu histologicznego
- Nowotwory gruczołowe i nabłonkowe
- Nowotwory neuroepitelialne
- Nowotwory neuroektodermalne
- Nowotwory, komórki rozrodcze i embrionalne
- Nowotwory, tkanka nerwowa
- Glejaka wielopostaciowego
- Glejak
- Gwiaździak
- Dyscypliny i działania behawioralne
- Testy psychologiczne
- Testy neuropsychologiczne
Inne numery identyfikacyjne badania
- 24-0143
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Clinical Data from the other study centers part of the Glioma Connectome Project (GCP) will be transferred pseudonymously.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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