Rare Subtypes of Gastrointestinal Cancers
- Conditions
- Cancer of Gastrointestinal Tract
- Registration Number
- NCT04838327
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
- Conditions precluding translational blood sampling
- Another concomitant cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility and translational analysis 2 years last patient 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.
- Secondary Outcome Measures
Name Time Method Quality of Life by EORTC QLQ-C30 2 years last patient 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.
Progression Free Survival 2 years last patient Time from inclusion to progression according to RECIST version 1.1
Overall Survival 2 years last patient Time from inclusion til death from any cause
Response rate 6 months post-treatment According to RECIST version 1.1
Trial Locations
- Locations (1)
Department of Oncology, Aarhus University Hospital
🇩🇰Aarhus N, Denmark