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

This study is currently recruiting participants.

See

Contacts and Locations

Verified March 2017 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: March 6, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

December 29, 2011

Last Updated Date

March 6, 2017

Actual Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression Free Survival [ Time Frame: Throughout study participation ]

Prospective cohort study.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01503190 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Breast Cancer
Breast Cancer and Pregnancy

Intervention ^ICMJE

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

July 2021

Estimated Primary Completion Date

December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact: Emily Rozzo

303-724-6077

emily.rozzo@ucdenver.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01503190

Other Study ID Numbers ^ICMJE

09-0583.cc

Has Data Monitoring Committee

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:

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Virginia Borges, MD, MMSc

University of Colorado, Denver

PRS Account

University of Colorado, Denver

Verification Date

March 2017

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

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