跳至主要内容
临床试验/NCT04074720
NCT04074720招募中不适用

Prospective Breast Cancer Biospecimen Collection

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Tumor biomarker identification

研究概览

简要总结

Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death

详细描述

This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults >18 years old at time of consent
  • Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.
  • Patients with carcinoma in situ or invasive breast cancer
  • Patient must be undergoing one of the following:
  • definitive surgical tumor resection for breast cancer OR
  • placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR
  • neurosurgical resection of a brain metastasis from primary breast cancer.

排除标准

  • <18 years old
  • Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.
  • Active drug/alcohol dependence or abuse history

结局指标

主要结局

Tumor biomarker identification

时间窗: Up to 5 years

Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).

次要结局

  • Laboratory-based breast cancer tumor genomic profile(Up to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验