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. |
ClinicalTrials.gov Identifier: NCT01503190 |
Recruitment Status
:
Recruiting
First Posted
: January 2, 2012
Last Update Posted
: January 19, 2018
|
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
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 |
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 |
|
||||
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 |
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:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 18 Years to 49 Years (Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
|
||||
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 |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | University of Colorado, Denver | ||||
Study Sponsor | University of Colorado, Denver | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | University of Colorado, Denver | ||||
Verification Date | January 2018 |