The Immune System's Response to Young Women's Breast Cancer
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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 |
- 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) |
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 |
Women who are between the ages of 18 and 49 who have been diagnosed with breast cancer. Need not be in active treatment.
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| Contact: Elizabeth Manthey, BS | 720-848-8031 | elizabeth.manthey@ucdenver.edu |
| United States, Colorado | |
| University of Colorado Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| 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 8, 2013 |
| 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 May 19, 2013