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The ctDNA-RECIST Trial Part One
Sponsor: Karen-Lise Garm Spindler
Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
Official title: ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
167
Start Date
2025-01-15
Completion Date
2030-09-01
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (2)
Aarhus University Hospital
Aarhus, Denmark
Department pf Oncology, Vejle Hospital
Vejle, Denmark