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

NCT06896162 | Recruiting DMC

• 1 other identifier: LCCC2437-DCT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The rate of genome informed therapy (GIT) orders

  The rate of genome informed therapy (GIT) orders for Level 1/2 GIT will be compared against an estimated baseline historical GIT order.

  2 years

Secondary Outcomes (9)

• Overall survival (OS)

  2 years

• The rate of genome informed therapy (GIT) orders by site

  2 years

• The rates of consent to UNC Health biomarker-selective clinical trials

  2 years

• The reasons for non-consent

  2 years

• Overall Survival in subjects who are eligible for Level 1/2 genome-informed therapy (GIT)

  2 years

Study Arms (1)

The potential candidates for genome-informed targeted therapy

OTHER

Potential candidates have a stage IV solid tumor malignancy (breast, lung, colorectal, and bladder cancer) for whom NGS testing is planned to be obtained before first or second-line therapy.

Other: Expert Review; Other: Blood or tissue samples collection.; Other: The Precision Oncology Navigation

Interventions

Expert Review OTHER

Expert reflexive review of next-generation sequencing (NGS) results will be visible in electronic health records (EPIC) for provider review at the University of North Carolina Health System. Expert review will include recommendations for Genome-informed therapy (GIT), identification of available clinical trials, recommendations for additional testing, and/or referrals for genetic counseling.

The potential candidates for genome-informed targeted therapy

Blood or tissue samples collection. OTHER

Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.

The potential candidates for genome-informed targeted therapy

The Precision Oncology Navigation OTHER

The precision oncology navigator will coordinate the collection of blood and /or tissue for next-generation sequencing (NGS), as well as order the NGS if not already ordered. Precision oncology navigator will also assist in NGS financial aid applications, if applicable.

The potential candidates for genome-informed targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
• Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
• Age ≥ 18 years at the time of consent.
• ECOG or Karnofsky Performance Status of 0-2.
• Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer
• The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting
• A genomic tumor test has not been ordered or has been ordered but not resulted.

You may not qualify if:

• Subjects with an active concurrent malignancy.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center, University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Carrie Lee

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Drotts

CONTACT

919-445-4872; stephanie_drotts@med.unc.edu

Douglas Kirk

CONTACT

919-445-6240; douglas_kirk@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: hybrid decentralized

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 26, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)