RECRUITING

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

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 hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers). The purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1/2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.

Official Title

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

Quick Facts

Study Start:2025-06-27
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06896162

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:18 Years
Sexes Eligible for Study:ALL
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

Stephanie Drotts
CONTACT
919-445-4872
stephanie_drotts@med.unc.edu
Douglas Kirk
CONTACT
919-445-6240
douglas_kirk@med.unc.edu

Principal Investigator

Carrie Lee
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

Lineberger Comprehensive Cancer Center, University of North Carolina
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Carrie Lee, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer 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 Date2025-06-27
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-06-27
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • next-generation sequencing (NGS)
  • expert review of NGS
  • precision oncology
  • precision oncology navigator
  • genome informed therapy (GIT)
  • biomarker-directed clinical trials

Additional Relevant MeSH Terms

  • Solid Tumor Malignancies
  • Metastatic Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Bladder Cancer