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A Biological Sample Collection Protocol of Women With and Without Breast Cancer | Clinical Trials | Clareo Health

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A Biological Sample Collection Protocol of Women With and Without Breast Cancer

A Biological Sample Collection Protocol of Women With and Without Breast Cancer: Hoosier Oncology Group Study BRE06-120 for the Analytical Proteomics Team

NCT00472589•Hoosier Cancer Research Network

View on ClinicalTrials.gov

Summary

The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from women with breast cancer and plasma, serum, whole blood from healthy women, which will be made available to researchers for biomarker analysis.

Detailed Description

OUTLINE: This is a multi-center study. The treatment plan for each breast cancer subject will be determined at the discretion of the treating physician and subject. This protocol does not prescribe any particular standard of care treatment. There will be no treatment for the healthy volunteers.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•FOR WOMEN WITH BREAST CANCER
•Histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast.
•Preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic).
•Female.
•Age \> 18 years at the time of consent.
•Written informed consent and HIPAA authorization for release of personal health information.
•FOR HEALTHY VOLUNTEERS
•No known history of invasive malignancy or ductal carcinoma in situ. Volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers.
•Female
•Age \> 18 years at the time of consent.
+1 more criteria

Exclusion Criteria

•Females must not be pregnant.

Locations (11)

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States

Cancer Care Center of Southern Indiana

Bloomington, Indiana, United States

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, United States

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, United States

Arnett Cancer Care

Lafayette, Indiana, United States

Horizon Oncology Center

Lafayette, Indiana, United States

Medical Consultants, P.C.

Muncie, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Key Dates

Start Date

May 1, 2007

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

August 23, 2016

Enrollment

400

ACTUAL participants

Conditions

Breast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Biological Sample Collection Protocol of Women With and Without Breast Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer