Core Biopsies for Establishing a Breast Tumor Tissue Repository

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT02250352
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cytology specimen collection procedure — OTHER
    Correlative studies

Study Details

This research trial establishes a breast tumor tissue repository from core biopsies. Collecting breast tissue from core biopsies may allow doctors to learn more about the biology of breast cancer and to analyze proteins, genes, and other components of tumor cells. It may also allow doctors to conduct future studies to help understand how breast cancer grows and how it responds to different types of therapy. This will help doctors develop better breast cancer therapies and better tests to help make treatment decisions.

Key Dates

Start date
Nov 14, 2013
Status verified
May 2026
Primary completion
Nov 14, 2026
Completion
Nov 14, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Cohort I (newly diagnosed, surgery before systemic therapy)
    Patients undergo baseline and, if applicable, follow-up core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases. Patients who experience a recurrence or progression after therapy undergo additional core biopsies at the time of recurrence. Blood and tissue sample collections will also be gathered along with completion of surveys.
  • Arm: Cohort II (newly diagnosed, systemic therapy before surgery)
    Patients undergo core biopsy, blood and tissue sample collections, and completion of surveys. Patients also undergo biopsies at a specific time point following the initiation of standard systemic therapy.
  • Arm: Cohort III (patients with suspicious breast mass)
    Patients undergo core biopsy, blood and tissue sample collections, and surveys. Patients who have BIRADS 4b, 4c, and 5 lesions may undergo up to 6 additional 6 core biopsies.
  • Arm: Cohort IV (breast cancer recurrence or progression)
    Patients undergo core biopsy, blood and tissue sample collections, and completion of surveys. Patients may also undergo 1-3 extra core biopsies.
  • Arm: Cohort V (solid tumor suspicious of originating from breast primary)
    Patients will undergo a confirmatory biopsy for diagnosis in which 1-3 additional core biopsies will be obtained for research purposes. Patients will also undergo blood and tissue sample collections and completion of surveys.

Primary Outcome Measure

Development of a baseline and serial breast cancer core biopsy repository within the USC/Norris Comprehensive Cancer Center Women's Cancer Program [ Time Frame: Up to 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Ameria Casillas-Lopez
[email protected]
323-865-0804
Julie Lang, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CA

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