NCT06562348 The ctDNA-RECIST Trial Part One
| NCT ID | NCT06562348 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Karen-Lise Garm Spindler |
| Condition | Gastrointestinal Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 167 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 167 participants in total. It began in 2025-01-15 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Karen-Lise G Spindler, MD, Prof
PRINCIPAL INVESTIGATOR
Department of Oncology, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06562348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06562348 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06562348 currently recruiting?
Yes, NCT06562348 is actively recruiting participants. Contact the research team at k.g.spindler@rm.dk for enrollment information.
Where is the NCT06562348 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Vejle, Denmark.
Who is sponsoring the NCT06562348 clinical trial?
NCT06562348 is sponsored by Karen-Lise Garm Spindler. The principal investigator is Karen-Lise G Spindler, MD, Prof at Department of Oncology, Aarhus University Hospital. The trial plans to enroll 167 participants.