RECRUITING

The PREDICT Registry:

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 is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.

Official Title

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy

Quick Facts

Study Start:2018-02-27
Study Completion:2035-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03448926

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:30 Years to 85 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Steven C Shivers, PhD
CONTACT
813-215-1749
sshivers@preludedx.com
Leona Hamrick, DHSc
CONTACT
727-244-6411
lhamrick@preludedx.com

Principal Investigator

Troy Bremer, PhD
PRINCIPAL_INVESTIGATOR
PreludeDx
Pat W Whitworth, MD
STUDY_CHAIR
PreludeDx
Rachel Rabinovitch, MD
STUDY_CHAIR
University of Colorado, Denver
Pat Borgen, MD
STUDY_CHAIR
Maimonides Medical Center

Study Locations (Sites)

Arizona Center for Cancer Care
Phoenix, Arizona, 85027
United States
Sutter Institute for Medical Research
Sacramento, California, 95816
United States
Mills-Peninsula Medical Center
San Mateo, California, 94019
United States
University of Colorado Denver
Aurora, Colorado, 80045
United States
UC Health - Memorial Hospital, Colorado Springs
Colorado Springs, Colorado, 80909
United States
St. Joseph's Hospital Tampa
Tampa, Florida, 33614
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, 02190
United States
Comprehensive Breast Care
Troy, Michigan, 48098
United States
Maimonides Cancer Center
Brooklyn, New York, 11220
United States
Cleveland Clinic Akron General
Akron, Ohio, 44302
United States
Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, 44195
United States
The Ohio State University
Columbus, Ohio, 43212
United States
Nashville Breast Center
Nashville, Tennessee, 37203
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: PreludeDx

  • Troy Bremer, PhD, PRINCIPAL_INVESTIGATOR, PreludeDx
  • Pat W Whitworth, MD, STUDY_CHAIR, PreludeDx
  • Rachel Rabinovitch, MD, STUDY_CHAIR, University of Colorado, Denver
  • Pat Borgen, MD, STUDY_CHAIR, Maimonides Medical Center

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 Date2018-02-27
Study Completion Date2035-12

Study Record Updates

Study Start Date2018-02-27
Study Completion Date2035-12

Terms related to this study

Keywords Provided by Researchers

  • DCIS
  • molecular testing
  • risk of recurrence
  • treatment decision
  • decision impact
  • predictive

Additional Relevant MeSH Terms

  • DCIS