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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01503190
Recruitment Status : Recruiting
First Posted : January 2, 2012
Last Update Posted : July 10, 2018
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease
Breast Cancer Breast Cancer and Pregnancy

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
Estimated Enrollment : 800 participants
Observational Model: Other
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
Actual Study Start Date : July 21, 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Throughout study participation ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study is restricted by gender due to the population of interest being women with pregnancy associated breast cancer and appropriately matched age controls.
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  1. Females >18.
  2. Histological or cytological confirmation of breast cancer.
  3. 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.
  4. 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.
  5. Any clinical stage allowed.
  6. 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.
  7. Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for safety reasons.
  8. 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.
  9. 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.

Exclusion Criteria:

  1. 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.
  2. 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.)
  3. Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01503190

Contact: Emily Rozzo 303-724-6077

United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Rozzo    303-724-6077    EMILY.ROZZO@UCDENVER.EDU   
Principal Investigator: Virginia Borges, MD, MMSc         
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Virginia Borges, MD, MMSc University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT01503190     History of Changes
Other Study ID Numbers:
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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