- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01075893
Changes in Stem Cells of the Colon in Response to Increased Risk of Colorectal Cancer
Colorectal cancer is a common disease worldwide. Increasing evidence is demonstrating that colorectal cancers arise from 'cancer stem cells.' Stem cells in the colon reside at the bottom of thousands of microscopic crypts throughout the wall of the colon. They create all the cells lining the bowel wall. These cells are created in the base of the crypt and ascend to the top acquiring the characteristics of mature cells of the bowel wall as they ascend.
It is now thought that colorectal cancer cells arise from stem cells where the genetic material regulating growth and division of the stem cell has become defective. This leads to unregulated production of cells which in turn have defective genetic information and cancer formation.
Prior studies have demonstrated that the earliest changes before a cancer develops are changes in cellular proliferation. Now that reliable markers to identify stem cells have been found, the researchers aim to investigate stem cell numbers and changes in distribution in those at normal risk of colorectal cancer and those at higher risk. The researchers hypothesise that changes in cellular proliferation at the top of the crypt in individuals at higher risk of colorectal cancer are due to a change in the number of stem cells in the crypt base.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Tyne & Wear
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Ashington, Tyne & Wear, 영국, NE63 9JJ
- Wansbeck General Hospital
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North Shields, Tyne & Wear, 영국, NE29 8NH
- North Tyneside Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Referred for endoscopy at participating centre
Exclusion Criteria:
- Age <16 or >85
- Familial polyposis syndrome
- Lynch syndrome
- Known colorectal tumour
- Previous colorectal resection
- Pregnancy
- Chemotherapy in last 6 months
- Therapy with aspirin/other nonsteroidal anti-inflammatory drug (NSAID)
- Other immunosuppressive medication
- Incomplete left sided examination
- Colorectal carcinoma found at endoscopy
- Iatrogenic perforation at endoscopy
- Colorectal cancer on histology
- Microscopic colitis on histology
For the colitis group
- Simple clinical colitis activity index (SCCAI) score > 5
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Adenomatous polyp
Patients who have begun the polyp-cancer sequence (ie.
are in polyp surveillance after excision of a prior adenomatous polyp) will be used to test those patients at higher risk of colorectal.
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Patients at normal risk of cancer
Patients found to have endoscopically and histological normal mucosa.
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Ulcerative colitis
Patients who are under surveillance for known ulcerative colitis will be used to test those patients at higher risk of colorectal.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Number of stem cells in the colonic crypt
기간: On day of endoscopy
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On day of endoscopy
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Stem cell position in colonic crypt
기간: On day of endoscopy
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On day of endoscopy
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공동 작업자 및 조사자
수사관
- 수석 연구원: Iain JD McCallum, MBChB MRCS, Newcastle University, UK
- 연구 의자: John C Mathers, PhD, Newcastle University, UK
- 연구 책임자: Seamus B Kelly, MD FRCS, Newcastle University, UK
- 연구 책임자: Mike Bradburn, MD FRCS, Northumbria NHS Foundation Trust
간행물 및 유용한 링크
일반 간행물
- Dronamraju SS, Coxhead JM, Kelly SB, Burn J, Mathers JC. Cell kinetics and gene expression changes in colorectal cancer patients given resistant starch: a randomised controlled trial. Gut. 2009 Mar;58(3):413-20. doi: 10.1136/gut.2008.162933. Epub 2008 Oct 31.
- Barker N, van Es JH, Kuipers J, Kujala P, van den Born M, Cozijnsen M, Haegebarth A, Korving J, Begthel H, Peters PJ, Clevers H. Identification of stem cells in small intestine and colon by marker gene Lgr5. Nature. 2007 Oct 25;449(7165):1003-7. doi: 10.1038/nature06196. Epub 2007 Oct 14.
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. .
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