- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00693836
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
Resource for the Study of Lung Cancer Epidemiology in North Trent
RATIONALE: Gathering information about genetic and environmental factors from patients with lung cancer and their partners and first-degree relatives may help doctors learn more about the disease.
PURPOSE: This clinical trial is looking at the patterns, causes, and control of disease in patients with lung cancer in the North Trent (England) region.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
Primary
- To establish a resource bank of high quality genomic and plasma DNA and tumor and serum samples linked to clinical data obtained from detailed family history and lifestyle questionnaires from patients with lung cancer and from their partners and first-degree relatives for genetic epidemiology studies of lung cancer.
Secondary
- To study single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples from patients with lung cancer and from their partners and first-degree relatives.
- To study genetic changes of lung cancer in plasma DNA samples from patients with lung cancer and from their partners and first-degree relatives.
OUTLINE: This is a multicenter study.
Patients and their partners complete a detailed, interview-based questionnaire to assess their environmental risk factors for cancer. Information on past medical, social, occupational, and smoking history as well as family history, including any malignancies diagnosed and subsequent causes of death, is collected. First-degree relatives of patients complete an interview-based questionnaire about smoking, occupational, and cancer history. Relatives of patients' partners complete a telephone-administered questionnaire only.
Medical records of patients are reviewed to obtain information on pathological diagnosis and laboratory number, date of diagnosis, stage of disease, performance status, co-morbidities, and treatment plan. Medical records of partners may also be reviewed to obtain information on the incidence of smoking-related malignancies (i.e., cancer of the lung, larynx, esophagus, stomach, bladder, or head and neck).
Patients and their partners and first-degree relatives undergo blood sample collection for laboratory studies. Previously collected tumor samples are obtained from patients. Plasma DNA, lymphocyte DNA, and tumor DNA are analyzed by polymerase chain reaction (PCR) to identify loss of heterozygosity (LOH) between genomic (lymphocyte) DNA and the tumor and plasma DNA. Specific tumor-associated mutations are also analyzed by real-time PCR. Single nucleotide polymorphism studies, including common gene polymorphisms (metabolic genes, DNA repair genes, and tumor suppressor genes), in lung cancer families are also conducted.
A statistical model will be developed for future analysis and will include correlations in genetic alterations in DNA isolated from tumor and plasma, familial aggregation studies, and genetic analysis studies.
PROJECTED ACCRUAL: A total of 2,000 participants (500 patients and 1,500 partners and first-degree relatives [controls]) will be accrued for this study.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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England
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Sheffield, England, 영국, S1O 2SJ
- 모병
- Cancer Research Centre at Weston Park Hospital
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연락하다:
- Penella J. Woll, MD, PhD
- 전화번호: 44-114-226-5206
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Patient meeting the following criteria:
- Pathologically confirmed lung cancer or planning to undergo lung cancer surgery pending pathological confirmation
- Evidence of active disease (i.e., not in remission)
Meets 1 of the following criteria:
- 60 years of age and under
- Has a first-degree relative with lung cancer who is 60 years of age and under
- Has two or more first- or second-degree relatives with lung cancer at any age
Control meeting the following criteria:
- Co-habiting partner of patient OR first-degree relative of patient or their partner
- 18 years of age and over
- Resides within the North Trent Cancer Network region
PATIENT CHARACTERISTICS:
- Able and willing to complete study procedures
PRIOR CONCURRENT THERAPY:
- Not specified
공부 계획
연구는 어떻게 설계됩니까?
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
---|
Establishment of a resource bank of high quality genomic and plasma DNA and tumor and serum samples
|
2차 결과 측정
결과 측정 |
---|
Analysis of single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples
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Genetic changes of lung cancer in plasma DNA samples
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공동 작업자 및 조사자
수사관
- 수석 연구원: Penella J. Woll, MD, PhD, Cancer Research Centre at Weston Park 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 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CRC-WPH-USMS-ReSoLuCENT
- CDR0000589308 (레지스트리 식별자: PDQ (Physician Data Query))
- EU-20826
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. .
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