Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06562348

The ctDNA-RECIST Trial Part One

Led by Karen-Lise Garm Spindler · Updated on 2025-05-01

167

Participants Needed

2

Research Sites

293 weeks

Total Duration

On this page

Sponsors

K

Karen-Lise Garm Spindler

Lead Sponsor

V

Vejle Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The ctDNA-RECIST Trial Part One

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Incurable metastatic gastrointestinal cancer
  • Indication for first or second-line systemic treatment
  • Measurable disease according to RECIST v.1.1
  • CT scan of chest and abdomen less than 30 days old at treatment start
  • Age at least 18 years
  • ECOG performance status 0-2
  • Clinically eligible for systemic palliative treatment as decided by investigator
  • Adequate bone marrow, liver, and kidney function for chemotherapy
  • Use of anticonception for fertile women and male patients with fertile partners
  • Written and verbal informed consent
Not Eligible

You will not qualify if you...

  • Incapacity, frailty, disability, or comorbidity incompatible with combination chemotherapy
  • Other active cancer except non-melanoma skin cancer or cervical carcinoma in situ
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Aarhus University Hospital

Aarhus, Denmark, 8000

Actively Recruiting

2

Department pf Oncology, Vejle Hospital

Vejle, Denmark, 7100

Actively Recruiting

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Research Team

K

Karen-Lise G Spindler, MD, Prof

CONTACT

T

Torben F Hansen, MD, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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