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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Tamika Wong, MPH
- 전화번호: 212-434-4836
- 이메일: twong4@northwell.edu
연구 연락처 백업
- 이름: Randy D'Amico, MD
- 전화번호: 212-434-3900
- 이메일: rdamico8@northwell.edu
연구 장소
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New York
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New York, New York, 미국, 10075
- 모병
- Lenox Hill Brain Tumor Center
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부수사관:
- David Langer, MD
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부수사관:
- Tamika Wong, MPH
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수석 연구원:
- Randy D'Amico, MD
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부수사관:
- John Boockvar, MD
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부수사관:
- Olivia Albers, NP
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연락하다:
- Randy D'Amico, MD
- 전화번호: 212-434-3900
- 이메일: rdamico8@northwell.edu
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연락하다:
- Tamik Wong, MPH
- 전화번호: 212-434-4836
- 이메일: twong4@northwell.edu
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부수사관:
- Netanel Ben-Shalom, MD, FNPS
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부수사관:
- Taylor Winby, NP
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부수사관:
- Elizabeth Lepski, NP
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Newly diagnosed and recurrent glioma (WHO grade II, III, IV) undergoing surgery
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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.
다른 이름들:
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:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Connectomic Metrics
기간: 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
기간: From enrollment up to 5 years.
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Network index |
From enrollment up to 5 years.
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Connectomic Metrics
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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KPS
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Randy D'Amico, MD, Northwell Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 24-0143
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Clinical Data from the other study centers part of the Glioma Connectome Project (GCP) will be transferred pseudonymously.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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