- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00897481
Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
- Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
- Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
Patient data related to relapse and recurrence is collected, if available.
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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England
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Leeds, England, 영국, LS9 7TF
- 모병
- Leeds Cancer Centre at St. James's University Hospital
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연락하다:
- Julia Newton Bishop, MD
- 전화번호: 44-113-206-4668
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Confirmed diagnosis of cutaneous melanoma
- Breslow thickness > 0.75 mm
- Has undergone sentinel lymph node biopsy
- No primary melanoma that has not originated in the skin
- No multiple primary melanomas
- Currently under clinical followup OR discharged from follow up within the past 3 months
PATIENT CHARACTERISTICS:
- No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Predictive model for sentinel lymph node biopsy positivity
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Survival model for relapse
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Genetic determinants in primary melanomas that predict a metastatic phenotype
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공동 작업자 및 조사자
수사관
- 연구 의자: Julia Newton Bishop, MD, Leeds Cancer Centre at St. James's University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .