The ctDNA-RECIST Trial Part One

PHASE2RecruitingINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

September 1, 2029

Study Completion Date

September 1, 2030

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."

Trial Locations (2)

7100

RECRUITING

Department pf Oncology, Vejle Hospital, Vejle

8000

RECRUITING

Aarhus University Hospital, Aarhus

All Listed Sponsors
collaborator

Vejle Hospital

OTHER

lead

Karen-Lise Garm Spindler

OTHER