- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07636252
Ex Vivo Drug Response Profiling and Outcome Prediction in Lung Adenocarcinoma
연구 개요
상세 설명
Non-small cell lung cancer (NSCLC) treatment decisions often rely on DNA sequencing, which only partially captures the tumor's mutational landscape and may miss other complex resistance mechanisms. Consequently, an unbiased functional drug screen is essential to rapidly identify optimal next-line therapies. Current drug sensitivity testing (DST) is limited by inefficient live tumor cells isolation. To address this, a rapid, unbiased DST platform utilizing FDA-approved targeted therapies was developed. Our approach uses malignant pleural effusions (MPEs) as a rich source of viable tumor cells. Because MPEs are highly heterogeneous, tumor cells are first identified via EpCAM flow cytometry, and the sample is enriched for tumor cells by depleting CD45+ immune cells using antibody-coated magnetic beads. These enriched tumor cells are then seeded into drug-containing plates. Following 72-hour incubation, cell viability is assessed using the CellTiter-Glo assay. Treatment efficacy is determined by the degree of reduction in cell viability at a range of drug concentrations, where the most effective treatment is the drug that reduces cell viability at the lowest concentration range.
To link clinical outcome and ex-vivo drug response assays, the investigators systematically measure drug sensitivity and resistance of primary tumor cells ex-vivo using a diverse compound library for individual patients in need of treatment. By systematically analyzing ex-vivo drug response patterns, tumors should be functionally grouped, by response phenotype. While for the purpose of this study selection of a specific treatment will not be based on ex-vivo drug response assays, clinical response- and follow-up data of patients will be prospectively collected in parallel.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Israel
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Ramat Gan, Israel, 이스라엘, 5262100
- 모병
- Sheba medical center
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연락하다:
- Michael Peled, MD PhD
- 전화번호: 972-3-5308420
- 이메일: michael.peled@sheba.health.gov.il
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Presence of pleural effusion in patient with a diagnosis of a lung cancer or suspected to be diagnosed with lung cancer according to their CT imaging, who are in need for pleural effusion drainage due to shortness of breath, and are willing to donate effusion for ex-vivo drug sensitivity testing.
- Patient's written informed consent present.
- Ability to understand the nature of the trial and the trial related procedures and to comply with them.
Exclusion Criteria:
- negative cytology for malignancy in the last 6 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients with diagnosis of a Lung adenocarcinoma with the need of pleural drainage due to MPE
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Non-Interventional Study, patients go through pleural drainage due to shortness of breath
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Statistically significant correlation between patients' drug response by ex-vivo drug profiling and expected drug sensitivity according to genetic sequencing
기간: From enrollment until results of clinical genetic sequencing and drug sensitivity testing are obtained (within 3 weeks).
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Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive.
Results will be compared with the expected sensitivity of drugs according to the driver mutation found be genetic sequencing.
For example, in EGFR-driven lung cancer, the tumor cells are expected to be more sensitive to EGFR-targeting drugs than to ALK-targeting drugs.
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From enrollment until results of clinical genetic sequencing and drug sensitivity testing are obtained (within 3 weeks).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Accuracy of patients' drug response prediction by ex-vivo drug profiling
기간: from date of enrollment until progression (latest 24 months)
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Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive.
Results will be compared with clinical outcome of patient (response vs. progressive disease as defined by RECISET score)
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from date of enrollment until progression (latest 24 months)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SHEBA-18-5494-MP-CTIL
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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