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

Tracking Information
First Submitted Date	December 29, 2011
First Posted Date	January 2, 2012
Last Update Posted Date	January 19, 2018
Actual Study Start Date	July 21, 2009
Estimated Primary Completion Date	December 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: December 26, 2012)	Progression Free Survival [ Time Frame: Throughout study participation ]; Prospective cohort study.
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01503190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	The Immune System's Response to Young Women's Breast Cancer
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
Brief Summary	This study plans to learn more about the immune system's response to breast cancer in young women.
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.
Study Type	Observational
Study Design	Observational Model: Other; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	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
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.
Condition	Breast Cancer; Breast Cancer and Pregnancy
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: December 30, 2011)	800
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	July 2021
Estimated Primary Completion Date	December 2020 (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 49 Years (Adult)
Accepts Healthy Volunteers	No
Contacts	Contact: Emily Rozzo 303-724-6077 emily.rozzo@ucdenver.edu
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01503190
Other Study ID Numbers	09-0583.cc
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	University of Colorado, Denver
Study Sponsor	University of Colorado, Denver
Collaborators	Not Provided
Investigators	Principal Investigator: Virginia Borges, MD, MMSc University of Colorado, Denver
PRS Account	University of Colorado, Denver
Verification Date	January 2018