Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
- Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.
OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.
Patients' enzyme expression levels are compared with their clinical data.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Tokyo, 일본, 113-8519
- Tokyo Medical and Dental University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
<Inclusion criteria>
- Pathologically confirmed stage III colon adenocarcinoma
- Curatively resected (R0)
- Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy
- Provided written informed consent
<Exclusion criteria>
- Synchronous or metachronous multiple cancers
- Contraindications for fluorouracil-based chemotherapy
- Patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study
- Ineligible patients according to the investigator's judgement
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
기간: 5 years after the end of registration
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5 years after the end of registration
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Relationship between expression levels of enzymes and adverse effects
기간: 5 years after the end of registration
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5 years after the end of registration
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Disease-free survival
기간: Until the day on which an event reveals during the 5 year observational period
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Until the day on which an event reveals during the 5 year observational period
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Relapse-free survival
기간: Until the day on which an event reveals during the 5 year observational period
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Until the day on which an event reveals during the 5 year observational period
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kenichi Sugihara, MD, PhD, Tokyo Medical and Dental University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .