RECRUITING

A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.

Official Title

Chicago Alternative Prevention Study for Diverse Populations of High Risk Women

Quick Facts

Study Start:2019-05-30

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03729115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR * 5-years risk ≥ 6% for women 40-64 OR * 5-years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk \>= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR * Patients with history of chest wall radiation received before age 35. OR * To promote health equity, women of African Ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women. * Must be at least 25 years old. * Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures. * Be able to give informed consent. * Patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years. * Undergoing active cancer treatment at the time of enrollment. * Current pregnancy or plans for pregnancy within two years of enrollment. * Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI. * Breast surgery within two weeks of study entry. * Women with history of bilateral mastectomy are not eligible * History of kidney disease or abnormal kidney function. * History of dye allergy unless it can be mediated with antihistamines and/or steroids * Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR
* 5-years risk ≥ 6% for women 40-64 OR
* 5-years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk \>= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR
* Patients with history of chest wall radiation received before age 35. OR
* To promote health equity, women of African Ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women.
* Must be at least 25 years old.
* Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
* Be able to give informed consent.
* Patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years.
* Undergoing active cancer treatment at the time of enrollment.
* Current pregnancy or plans for pregnancy within two years of enrollment.
* Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
* Breast surgery within two weeks of study entry.
* Women with history of bilateral mastectomy are not eligible
* History of kidney disease or abnormal kidney function.
* History of dye allergy unless it can be mediated with antihistamines and/or steroids
* Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Cancer Clinical Intake Office

CONTACT

1-855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Olufunmilayo I Olopade, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Olufunmilayo I Olopade, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-30

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2019-05-30

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer