The ctDNA-RECIST Trial Part One

Recruiting now · Phase 2

Conditions studied: Gastrointestinal Neoplasm

In brief

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

Key facts

Study ID

NCT06562348

Run by

Karen-Lise Garm Spindler

People needed

167

Starts

2025-01-15

Expected to finish

2030-09-01

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Incurable metastatic gastrointestinal cancer
• Indication for first or second-line systemic treatment
• Measurable disease according to RECIST v.1.1
• CT of chest and abdomen less than 30 days old at time of treatment initiation
• Age at least 18 years
• ECOG performance status 0-2
• Clinically eligible systemic palliative treatment at investigators decision.
• Adequate bone marrow, liver and renal function allowing systemic chemotherapy
• Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
• Written and verbally informed consent

You may not qualify if…

• Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
• Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri
• Pregnant (positive pregnancy test) or breast-feeding women

Where it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Department pf Oncology, Vejle Hospital — Vejle, Denmark (enrolling)

Full record on ClinicalTrials.gov

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