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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise B Callesen, MD | Contact | +4578462535 | louicall@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Louise B Callesen, MD | Experimental Clinical Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 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 |
| D005767 |
| Gastrointestinal Diseases |