- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01866202
Study of Circulating and Tumor Biomarkers in Breast Cancer Patients
Aims: To evaluate the role of monoclonal antibodies in the detection of cancer specific antigens in blood and tumor tissue, and the potential use of these antibodies for future evaluation for therapy. Also, to evaluate the presence of circulating tumor cells (CTCs) and to study EMT (epithelial-mesenchymal) signature changes during chemotherapy.
Methods: To take 20mls of blood from advanced breast cancer patients before a new course of anti-cancer therapy, and another 20mls of blood 3 weeks after treatment. In addition, Consent will be obtained to cut 10-15 tissue sections from their archival tumor specimens. Whenever possible, the blood taking will be timed such that no additional needle prick will be done specifically for the purpose of the study, by coinciding it with standard blood taking which is required for the patient's treatment.
Importance of proposed research to science or medicine:Detection of tumor specific antigens in the blood may potentially reduce the need for more invasive biopsies for confirmation of diagnosis of cancer or follow-up of cancer in the future. The identification and development of antibodies specific to these tumor antigens or markers may offer future therapeutic options, or as a vehicle to deliver cytotoxic therapy. Identification of CTCs as well as understanding the changes that occur in EMT signature in these circulating tumor cells may serve as a means of potential means of prognostication and modification of therapy in the future.
Potential Benefits and Risks: Potential risks to the patient include that of blood taking (pain, feeling faint, infection). Patients will not benefit directly from the study but the knowledge gained may help the management of future patients.
Cancer biomarkers, such as antigens and circulating tumor cells, may be a potential area to developing new methods of diagnosis and treatment of cancer. Monoclonal antibiotics are now able to be identified and isolated that may specifically target progenitors of breast cancer as well as CTCs. The changes that occur to CTCs during treatment may serve as a means of prognostication, as well as allow for therapeutic modifications. Clinical correlative studies into these areas (MAbs and CTCs) will serve to determine the role of these in clinical application in the future.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Singapore, 싱가포르
- 모병
- Nationa University Hospital
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연락하다:
- Soo Chin Lee, MBBS, MRCP
- 전화번호: +65 6779 5555
- 이메일: Soo_Chin_Lee@nuhs.edu.sg
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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:
- Advanced breast cancer patients whose cancer have progressed and are due to start a new course of anti-cancer therapy.The patient needs to have had previous breast cancer surgery at NUH (lumpectomy or mastectomy) or a diagnostic core biopsy for breast cancer, and consent to allow for blood taking and access to archival tissue.
Exclusion Criteria:
- No available archival tumor specimen at NUH.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Detection of cancer specific antigens in blood and tumor tissue
기간: 1 year
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1 year
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Choo AB, Tan HL, Ang SN, Fong WJ, Chin A, Lo J, Zheng L, Hentze H, Philp RJ, Oh SK, Yap M. Selection against undifferentiated human embryonic stem cells by a cytotoxic antibody recognizing podocalyxin-like protein-1. Stem Cells. 2008 Jun;26(6):1454-63. doi: 10.1634/stemcells.2007-0576. Epub 2008 Mar 20.
- Tan HL, Fong WJ, Lee EH, Yap M, Choo A. mAb 84, a cytotoxic antibody that kills undifferentiated human embryonic stem cells via oncosis. Stem Cells. 2009 Aug;27(8):1792-801. doi: 10.1002/stem.109.
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. .