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A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial

NCT04786600 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-07-01

Study results available
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Summary

This randomized, phase 2 study will investigate the use of the Signatera ctDNA assay versus the standard scan-based approach to guide treatment in patients with metastatic colorectal cancer. The aim of this study will be to measure and compare the overall survival, progression-free survival, and best overall response while on study of patients whose treatment has been guided by these two approaches.

Conditions

Interventions

DEVICE

Signatera ctDNA assay

Subjects will be tested with the Signatera ctDNA assay every 2 weeks.

DRUG

pre-specified sequence of FDA-approved drugs and drug combinations

Subjects will receive treatment with a pre-specified sequence of FDA-approved drugs and drug combinations

Sponsors & Collaborators

  • Natera, Inc.

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Sherise Rogers, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2024-03-19
Completion
2024-03-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786600 on ClinicalTrials.gov