Rare Subtypes of Gastrointestinal Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer of Gastrointestinal Tract. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rare Subtypes of Gastrointestinal Cancers - Real-world Data and Liquid Biopsies
Overview
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.
Primary outcome measures
- Feasibility and translational analysis [Time frame: 2 years last patient]
Secondary outcome measures (4)
- Response rate [Time frame: 6 months post-treatment]
- Progression Free Survival [Time frame: 2 years last patient]
- Overall Survival [Time frame: 2 years last patient]
- Quality of Life by EORTC QLQ-C30 [Time frame: 2 years last patient]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Department of Oncology, Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT04838327 · 1-10-72-7-21