Collecting tissue samples from women with or without breast cancer
Breast Tissue/Body Fluids Repository
This study is collecting tissue, blood, and urine samples from women with and without breast cancer to create a database that helps researchers understand how breast cancer develops and progresses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT00899301 on ClinicalTrials.gov |
What this trial studies
This research focuses on collecting and storing tissue, blood, and urine samples from women diagnosed with breast cancer at various stages, as well as from healthy volunteers. The objective is to create a comprehensive database that includes various factors related to breast cancer, such as genetic and clinical data. Samples will be collected during medically indicated surgeries or biopsies, and a repository will be established to support future research on breast cancer development and progression. The study will also review patients' medical records over five years to assess the relationship between test results and health outcomes.
Who should consider this trial
Good fit: Ideal candidates include women with a suspected or confirmed diagnosis of breast cancer at any stage, as well as healthy volunteers willing to donate samples.
Not a fit: Patients who are not willing to donate tissue or body fluids or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of breast cancer biology and improve future diagnostic and treatment strategies.
How similar studies have performed: Other studies have successfully utilized similar approaches to collect and analyze biological samples for cancer research, indicating a promising avenue for future investigations.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: A. Bapsi Chakravarthy, MD — Vanderbilt-Ingram Cancer Center
- Study coordinator: VICC Clinical Trials Information Program
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.