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

This study is currently recruiting participants.
Verified May 2013 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 8, 2013
Last verified: May 2013
History of Changes

December 29, 2011
May 8, 2013
July 2007
December 2020   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: Throughout study participation ] [ Designated as safety issue: No ]
Prospective cohort study.
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Complete list of historical versions of study NCT01503190 on ClinicalTrials.gov Archive Site
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The Immune System's Response to Young Women's Breast Cancer
A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction

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

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.
Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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
Non-Probability Sample

Women who are between the ages of 18 and 49 who have been diagnosed with breast cancer. Need not be in active treatment.
  • Breast Cancer
  • Breast Cancer and Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
July 2021
December 2020   (final data collection date for primary outcome measure)

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.
Female
18 Years to 49 Years
No
Contact: Elizabeth Manthey, BS 720-848-8031 elizabeth.manthey@ucdenver.edu
United States
 
NCT01503190
09-0583.cc
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Virginia Borges, MD, MMSc University of Colorado, Denver
University of Colorado, Denver
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP