Observational study on rare gastrointestinal cancers and targeted treatments
Rare Subtypes of Gastrointestinal Cancers - Real-world Data and Liquid Biopsies
Aarhus University Hospital · NCT04838327
This study is testing how certain blood markers in patients with rare gastrointestinal cancers can help us understand how well targeted treatments are working for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT04838327 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the biological aspects of patients with rare subtypes of gastrointestinal cancers who are receiving targeted treatments. Participants will have blood samples collected at various points during their treatment to analyze cell-free DNA and identify tumor-specific mutations, as well as immune-related biomarkers. The study will include up to 130 patients and will correlate biological findings with treatment outcomes. The approach focuses on understanding how these biomarkers relate to the effectiveness of standard care treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with rare subtypes of gastrointestinal cancer, such as those with specific mutations like BRAF V600E.
Not a fit: Patients with conditions that prevent blood sampling or those with another concomitant cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of rare gastrointestinal cancers and improve targeted treatment strategies for patients.
How similar studies have performed: While there have been studies on gastrointestinal cancers, this specific focus on rare subtypes and their biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus N
- Department of Oncology, Aarhus University Hospital — Aarhus N, Denmark (RECRUITING)
Study contacts
- Principal investigator: Louise B Callesen, MD — Experimental Clinical Oncology
- Study coordinator: Louise B Callesen, MD
- Email: louicall@rm.dk
- Phone: +4578462535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer of Gastrointestinal Tract