- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04694391
Genomic Study of Relapse Esophageal Cancer After Radiotherapy
연구 개요
상세 설명
Tumor tissue of patients received radiotherapy with diagnosis of recurrence between Jan 1, 2010 and Dec 1, 2020 were collected retrospectively. Recurrence tumor tissue is collected between Dec 31, 2020 and Dec 31, 2022 prospectively. Blood and preradiotherapy tumor tissue were also collected to be as contrast. A total of 100 paired blood, preradiotherapy tumor tissue and relapse tumor tissue were collected. What is more, a total of 100 paired blood and preradiotherapy tumor tissue with diagnosis of no recurrence were collected. All samples were conducted with whole exome sequencing.
Here the investigators define recurrence period as within 2 years and no recurrence period as more than 3 years after radiotherapy.
Criteria of relapse: (1) pathologic diagnosis is squamous carcinoma before radiotherapy;(2) received radiotherapy; (3)pathologic diagnosis is also squamous carcinoma after radiotherapy; (4) clinical symptoms including feeding obstruction etc; (5) imaging evidence showed disease progression.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Kuaile Zhao, doctor
- 전화번호: 18017312534
- 이메일: kuaile_z@sina.com
연구 연락처 백업
- 이름: Jiaying Deng, doctor
- 전화번호: 18317088158
- 이메일: dengjiaying3@sina.com
연구 장소
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Shanghai, 중국, 200032
- 모병
- Fudan University Shanghai Cancer Center
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연락하다:
- Kuaile Zhao, doctor
- 전화번호: 18017312534
- 이메일: kuaile_z@sina.com
-
연락하다:
- Jiaying Deng, doctor
- 전화번호: 18317088158
- 이메일: dengjiaying3@sina.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Recurrence group: 100 paired relapsed tumor tissue,blood and preradiotherapy tumor tissue within 2 years after radiotherapy were collected.
No recurrence group:100 paired blood and preradiotherapy tumor tissue with more than 3 years after radiotherapy were collected
설명
Inclusion Criteria:
- pathologic diagnosis is squamous cell carcinoma before radiotherapy;
- pathologic diagnosis is squamous cell carcinoma after radiotherapy;
- received radiotherapy
- clinical symptoms including dysphagia, feeding obstruction, etc
- image evidence showed disease progression
- the period of recurrence was within 2 years after radiotherapy
Exclusion Criteria:
- pathologic diagnosis is not squamous cell carcinoma before radiotherapy;
- pathologic diagnosis is not squamous cell carcinoma after radiotherapy
- not received radiotherapy
- the period of recurrence was more than 2 years after radiotherapy
- the period of no recurrence was within 3 years after radiotherapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Recurrence
The period of recurrence was within 2 years after radiotherapy.
Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy.
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To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.
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No recurrence
The period was more than 3 years after radiotherapy and no recurrence signs were observed.
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To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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genomic characteristics of relapsed esophageal cancer
기간: through study completion, an average of 1 year
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gene mutations, copy number variants
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through study completion, an average of 1 year
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Kuaile Zhao, doctor, Fudan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .