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The ctDNA-RECIST Trial Part One

NCT06562348 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2025-05-01

No results posted yet for this study

Summary

A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.

Conditions

  • Gastrointestinal Neoplasm

Interventions

OTHER

Standard of care

Patients will be offered palliative systemic treatment according to standard of care. Response evaluation will be performed with the imaging-based RECIST according to standard guidelines. Treatment pauses according to institutional guidelines. Blood samples will be analyzed retrospectively to evaluate ctDNA.

OTHER

ctDNA-RECIST guided palliative systemic treatment

Patients are offered palliative systemic treatment according to standard of care. Response evaluation will be performed using ctDNA-RECIST. ctDNA is measured before start of treatment. If the baseline sample is ctDNA negative the patient is transferred to an observational cohort, and sampling procedures continues as in the standard arm. If the baseline sample is ctDNA positive the patient continues in the ctDNA-RECIST guided arm. Treatment response is evaluated according to ctDNA-RECIST, and further sampling follows a predefined decision schedule.

Sponsors & Collaborators

  • Vejle Hospital

    collaborator OTHER

  • Karen-Lise Garm Spindler

    lead OTHER

Principal Investigators

  • Karen-Lise G Spindler, MD, Prof · Department of Oncology, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2029-09-01
Completion
2030-09-01

Countries

  • Denmark

Study Locations

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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 NCT06562348 on ClinicalTrials.gov