The Immune System's Response to Young Women's Breast Cancer

NCT01503190 | Recruiting

• 1 other identifier: 09-0583.cc
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 5

Brief Summary

This study plans to learn more about the immune system's response to breast cancer in young women.

Conditions

Breast Cancer; Breast Cancer and Pregnancy

Keywords

Breast Cancer; Young Women; Pregnancy Associated Breast Cancer; Pregnancy; Premenopausal Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Prospective cohort study.

  Throughout study participation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study is restricted by gender due to the population of interest being women with pregnancy associated breast cancer and appropriately matched age controls.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over the age of 18 who have been diagnosed with breast cancer. Women over age 46 will serve as controls. Need not be in active treatment.

You may qualify if:

• Females \>18.
• Histological or cytological confirmation of breast cancer.
• For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides should be available or planned to be available after upcoming procedure.
• Patient should be willing to have fresh and/or fresh frozen tissue collected at time of core biopsy, definitive breast cancer surgery or clinically planned breast cancer metastasis biopsy/resection for research purposes as part of study procedures, if a procedure is in the future planning of the patient's treatment.
• Any clinical stage allowed.
• Written informed consent obtained prior to any initiation of study procedures in the case of subjects consented in clinic. Subjects consented outside of UCH, VVMC or SCC will be consented by phone and verbal informed consent will be obtained prior to any initiation of study procedures.
• Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for safety reasons.
• Women who have commenced or completed their breast cancer treatment may join this study by consenting to a retrospective tissue donation only consent of the protocol.
• Women who receive their care at a facility other than UCH, VVMC or SCC may join this study. These women will be consented utilizing the phone consent and will receive a copy of the consent in the mail, or they will consent online and print a copy of their online consent.

You may not qualify if:

• Known significant autoimmune condition \[ie Lupus, Crohne's disease or Rhuematoid Arthritis\], chronic oral steroid use, use of systemic immunomodulatory prescription drugs for any medical condition.
• The presence of other comorbid conditions known to significantly impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe COPD, uncontrolled infection or known HIV infection.)
• Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
• Subjects with a history of other malignancy besides current diagnosis of breast cancer who were diagnosed and treated within the last 5 years are excluded, with exception of cervical cancer definitively treated more than 2 years ago or non-melanomatous skin cancer.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (5)

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Denver Health Hospital Authority

Denver, Colorado, 80204, United States

RECRUITING

UCHealth Cherry Creek Medcial Center

Denver, Colorado, 80206, United States

RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

RECRUITING

UCHealth Lone Tree Medical Center

Lone Tree, Colorado, 80124, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, Blood and urine may be collected from subjects who were recently diagnosed. Subjects who were diagnosed after treatment begins or has ended will only be eligible for tissue donation section of study

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Virginia Borges, MD, MMSc

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Parris

CONTACT

720-848-4170; hannah.parris@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 2, 2012
• Study Start: July 21, 2009
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)