Collecting and Storing Tissue Samples From Women With or Without Breast Cancer

NCT00899301 | Recruiting

• 4 other identifiers: VICC BRE 03103P30CA068485VU-VICC-BRE-03103VU-VICC-030747
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or without breast cancer to study in the laboratory may help the study of cancer. PURPOSE: This research study is collecting and storing tissue samples from women with or without breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Creation of a tissue repository that contains DNA, RNA, or protein from tumor tissue or normal tissue, peripheral blood lymphocytes, and plasma that are linked to frozen and/or paraffin-embedded pathology specimens

  5 years

Study Arms (2)

Patients with Breast Cancer

Other: biologic sample preservation procedure

Patients without breast cancer

Other: biologic sample preservation procedure

Interventions

biologic sample preservation procedure OTHER

Tissue, urine and blood collection.

Patients with Breast Cancer; Patients without breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with and without breast cancer.

* Breast lesion which is suspected to be cancer or a known diagnosis of breast cancer (any stage, at any point in the disease trajectory) who agrees to donate tissue/body fluids. * Individuals of all races and ethnic groups are eligible for this trial. There is no restriction regarding age, race, or ethnicity. The trial is open to the accrual of men and women. * Must sign informed consent for study of tumor specimens as part of a research project. * Must give permission for their tumor specimens to be obtained from outside institutions for molecular analyses. * Must be willing to be followed for recurrence, relapse and death from disease. ELIGIBILITY CRITERIA FOR OPTIONAL PHYSICAL FUNCTION AND COGNITIVE ASSESSMENTS * Must be 60 years of age or older * Have completed initial round of cancer treatment * Have completed the optional online survey and opted-in for the physical function and cognitive assessments

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

RECRUITING

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• A. Bapsi Chakravarthy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VICC Clinical Trials Information Program

CONTACT

800-811-8480

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 22, 2004
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2024-08

Locations

US (1)