Rare Subtypes of Gastrointestinal Cancers
ConditionCancer of Gastrointestinal Tract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
A single-arm prospective observational translational study of biomarkers in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal Tract.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of a rare subtype of GI cancer including BRAF V600E mutation, MSI-H, HER2 and others
Diagnosis of cancer of the gastrointestinal tract may be made by histo- or cyto-pathology, or by clinical and imaging criteria
Planned for targeted treatment
Age 18 years or older
Disqualifiers
Conditions precluding translational blood sampling
Another concomitant cancer
Trial population
The study population consists of patients with rare subtypes of cancer of the gastrointestinal tract, who by standard of care are candidates for targeted treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Feasibility and translational analysis
Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis. We seek to describe the prognostic and predictive value of cfDNA, ctDNA and other markers, e.g. evaluate baseline cf- and ctDNA levels, fluctuations of cf- and ctDNA during treatment and follow up.
Time frame
2 years last patientSecondary outcomes
1
Response rate
According to RECIST version 1.1
Time frame
6 months post-treatment2
Progression Free Survival
Time from inclusion to progression according to RECIST version 1.1
Time frame
2 years last patient3
Overall Survival
Time from inclusion til death from any cause
Time frame
2 years last patient4
Quality of Life by EORTC QLQ-C30
Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Time frame
2 years last patientSponsors and contacts
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Source ClinicalTrials.gov