Rare Subtypes of Gastrointestinal Cancers

Study Overview
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Brief Summary
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A single-arm prospective observational translational study of biomarkers in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal Tract.

Detailed Description
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In this study, the investigators seek to investigate biological aspects in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal. The targeted treatment will be given as per standard of care. Translational blood samples will be drawn pre-treatment, before the third cycle of chemotherapy, and hereafter corresponding to the planned imaging during treatment and follow up. The total cell free DNA will be quantified in all samples. The samples will be analyzed for tumor specific mutations such as the KRAS, BRAF, and NRAS oncogenes, by ddPCR. Circulating tumor DNA will also be identified by hypermethylation markers, and a focused panel of next generation sequencing can be applied. The samples will also be analyzed for immune-related biomarkers. The investigators expect to include up to 130 patients. This is a purely observational translational study. Results will be analysed in relation to outcome data.

Official Title
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Rare Subtypes of Gastrointestinal Cancers - Real-world Data and Liquid Biopsies

Conditions
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Cancer of Gastrointestinal Tract

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Able to understand written information Consent to samples for translational research Exclusion Criteria: Conditions precluding translational blood sampling Another concomitant cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | According to RECIST version 1.1 | 6 months post-treatment | 
| Progression Free Survival | Time from inclusion to progression according to RECIST version 1.1 | 2 years last patient | 
| Overall Survival | Time from inclusion til death from any cause | 2 years last patient | 
| 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. | 2 years last patient |