Cancer of Gastrointestinal Tract
Conditions
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.
Interventions
None listed
Sponsors
Aarhus University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6 months post-treatment | According to RECIST version 1.1 |
| 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 |
| 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. |
Countries
Denmark
Contacts
Primary ContactLouise B Callesen, MD
Outcome results
None listed