MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer; Cancer; Solid Tumor; Colorectal Cancer; Bladder Cancer

• Registration Number: NCT05219734
• Lead Sponsor: Invitae Corporation

Brief Summary

This study recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay. This assay will be used to detect circulating tumor DNA (ctDNA) levels in the blood over time and hopefully contribute to improvements in residual disease detection methods for future patients.

Results from this assay will be provided to participants and providers but providers are not asked to change patient care based on this information.

Detailed Description

This study involves collection of tumor tissue (from a standard biopsy and/or surgery) as well as blood samples over time in order to allow the creation of a Personalized Cancer Monitoring (PCM) assay. Additional blood samples are taken throughout the patient's treatment and follow-up period.

Each participant will submit one blood sample when they begin participation in the research study. Participants will be asked to submit follow up samples several times per year (annually, at minimum), with the exact frequency varying by stage and type of cancer. In general, participants will not be asked to come into the clinic more frequently than their already needed clinic visits.

If the cancer-specific mutations identified by the PCM are detected in the blood samples provided as part of the study, this may would suggests that residual cancer may be present. This is an observational study comparing MRD results to standard of care methods and collecting provider and patient perspectives, using surveys. Physicians will be informed of all PCM results in the form of a clinical report. Physicians are not asked to base treatment decisions on these results.

Study Timeline

• Study Start: 2021-11-29
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse Free Survival	Measured through study completion, assessed yearly up to 3 years
Overall survival	Through study completion, up to 5 years

Trial Locations

Locations (2)

Columbus Regional Health; 🇺🇸 Columbus, Indiana, United States

Onslow Radiation; 🇺🇸 Jacksonville, North Carolina, United States