- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01231386
MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer
연구 개요
상태
정황
상세 설명
Current neoadjuvant or adjuvant treatment strategies do not allow for rationale incorporation of such agents. One needs tools to predict both de novo and acquired resistance to therapeutic agents. This is a difficult task, due to the compound nature of escape routes: tumor exposure is usually to a combination of therapeutic agents and the mechanisms of resistance are broad: intrinsic resistance due to existing mutations, or regulatory - miRNA, other epigenetic - alterations, polymorphisms, tumor cell adaptation via new mutations and activation of alternative pathways, lack of optimal pharmacokinetics/genomics, activation of efflux mechanisms, accelerated repair mechanisms are involved.
Similarly, not all patients who are candidates for primary surgical intervention to be followed by post-operative adjuvant therapy benefit from such systemic treatments. The mechanisms of resistance be it de novo in surviving stem cell/tumorigenic components, or acquired by cells left behind "dormant" after the surgical intervention, are not well delineated.
Breast tumors subjected to neoadjuvant chemotherapy allow for baseline and treatment-effected sampling. Characterization of core biopsy specimens of primary tumors procured prior to exposure to neoadjuvant therapy from different varieties of breast cancer subtypes, and of subsequent mid-treatment and intraoperative (procured during definitive surgery following completion of neoadjuvant therapy) samples should help to assess the predictive value of the pre-treatment and post-treatment miRNA expression profile for complete and near complete response, as a surrogate marker for survival. Similarly, patterns of de novo and acquired resistance may emerge when assessment of pre- and post treatment miRNA expression profiles are analyzed in a supervised manner of classification using pathological response as classifier. Samples obtained from patients with primary surgical removal of their tumors before any systemic treatment exposure on the other hand, will allow for determining markers of prognosis, and predictors for response to therapeutic targeting agents.
Time Perspective: Retrospective/Prospective
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope
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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:
- Female,
- Breast Cancer
- > 18 years,
- regardless of histology, treatment phase, or stage
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Performance of miRNA profiling from tumor samples from primary breast tumors
기간: 3 years after completion of sample collection
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3 years after completion of sample collection
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Assessment of miRNA profiles from blood/serum samples from patients at baseline, and if feasible, at different time points
기간: 3 years after completion of sample collection
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3 years after completion of sample collection
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Analysis of miRNA findings and correlate miRNA patterns of expression in tumor, lymph nodes -if available- and in serum
기간: 3 years after competion of sample collection
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3 years after competion of sample collection
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Correlation of classic tumor markers such as estrogen and progesterone receptor (ER,PR), and HER2 expression with tumor stage and grade
기간: 3 years after completion of sample collection
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3 years after completion of sample collection
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Determination of specific miRNA functions
기간: 3 years after completion of sample collection
|
3 years after completion of sample collection
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Determination of ability to knock down functionally relevant overexpressed miRNAs by miR-sponge/antagomirs
기간: 3 years after completion of sample collection
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3 years after completion of sample collection
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Design of prospective pilot phase I-II trials to interfere with dysfunctional/dysregulated miRNA expression
기간: 3 years after completion of sample collection
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3 years after completion of sample collection
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공동 작업자 및 조사자
수사관
- 수석 연구원: George Somlo, MD, City of Hope Medical Center
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 연구와 관련된 용어
기타 연구 ID 번호
- 09147
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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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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