A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction

University of Colorado, Denver5 个研究点分布在 1 个国家目标入组 800 人2009年7月21日

适应症Breast Cancer Breast Cancer and Pregnancy

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Breast Cancer
发起方: University of Colorado, Denver
入组人数: 800
试验地点: 5
主要终点: Progression Free Survival
状态: 招募中
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This study plans to learn more about the immune system's response to breast cancer in young women.

详细描述

The investigators will be looking at the level of immune suppression in different types of breast cancer. The investigators will use blood, urine, and tissue samples from patients with Pregnancy Associated Breast Cancer (PABC) versus non-PABC, as well as comparing different types of breast cancer. If tissue sampling permits, the investigators may use some of the breast cancer tissue to develop models for human cancer for drug targeting. Understanding the immune response and suppression in different types of cancer will help us understand mechanisms involved in breast cancer better and help the investigators in developing new treatment in the future.

注册库

clinicaltrials.gov

开始日期

2009年7月21日

结束日期

2027年7月1日

最后更新

3个月前

研究类型

Observational

性别

Female

研究者

发起方

University of Colorado, Denver

责任方

Sponsor

入排标准

入选标准

•Histological or cytological confirmation of breast cancer.
•For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides should be available or planned to be available after upcoming procedure.
•Patient should be willing to have fresh and/or fresh frozen tissue collected at time of core biopsy, definitive breast cancer surgery or clinically planned breast cancer metastasis biopsy/resection for research purposes as part of study procedures, if a procedure is in the future planning of the patient's treatment.
•Any clinical stage allowed.
•Written informed consent obtained prior to any initiation of study procedures in the case of subjects consented in clinic. Subjects consented outside of UCH, VVMC or SCC will be consented by phone and verbal informed consent will be obtained prior to any initiation of study procedures.
•Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for safety reasons.
•Women who have commenced or completed their breast cancer treatment may join this study by consenting to a retrospective tissue donation only consent of the protocol.
•Women who receive their care at a facility other than UCH, VVMC or SCC may join this study. These women will be consented utilizing the phone consent and will receive a copy of the consent in the mail, or they will consent online and print a copy of their online consent.

排除标准

•Known significant autoimmune condition \[ie Lupus, Crohne's disease or Rhuematoid Arthritis\], chronic oral steroid use, use of systemic immunomodulatory prescription drugs for any medical condition.
•The presence of other comorbid conditions known to significantly impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe COPD, uncontrolled infection or known HIV infection.)
•Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
•Subjects with a history of other malignancy besides current diagnosis of breast cancer who were diagnosed and treated within the last 5 years are excluded, with exception of cervical cancer definitively treated more than 2 years ago or non-melanomatous skin cancer.