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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01503190
First received: December 29, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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


Condition
Breast Cancer
Breast Cancer and Pregnancy

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Throughout study participation ] [ Designated as safety issue: No ]
    Prospective cohort study.


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


Estimated Enrollment: 800
Study Start Date: July 2007
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Detailed Description:

The investigators will be looking at the level of immune suppression in different types of breast cancer. The investigators will use blood, urine, and tissue samples from patients with Pregnancy Associated Breast Cancer (PABC) versus non-PABC, as well as comparing different types of breast cancer. If tissue sampling permits, the investigators may use some of the breast cancer tissue to develop models for human cancer for drug targeting. Understanding the immune response and suppression in different types of cancer will help us understand mechanisms involved in breast cancer better and help the investigators in developing new treatment in the future.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women who are between the ages of 18 and 49 who have been diagnosed with breast cancer. Need not be in active treatment.

Criteria

Inclusion Criteria:

  • Females 50 or younger
  • Histological or cytological confirmation of breast cancer
  • Any clinical stage is allowed

Exclusion Criteria:

  • Any known autoimmune condition, chronic steroid use, underlying immune disease (other than breast cancer), use of immunomodulatory prescription drugs for any medical condition.
  • The presence of other comorbid conditions known to impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe chronic obstructive pulmonary disease (COPD), uncontrolled infection or known HIV infection.)
  • Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
  • Diagnosed with another type of cancer within 5 years except for breast cancer, cervical or non-melanomatous skin cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503190

Contacts
Contact: Tiffany Colvin, BS 720-848-0664 Tiffany.Colvin@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Virginia Borges, MD, MMSc University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01503190     History of Changes
Other Study ID Numbers: 09-0583.cc
Study First Received: December 29, 2011
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Breast Cancer
Young Women
Pregnancy Associated Breast Cancer
Pregnancy
Premenopausal Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014