Rare Subtypes of Gastrointestinal Cancers

Cancer of Gastrointestinal Tract Clinical Trial

Official title:

Rare Subtypes of Gastrointestinal Cancers - Real-world Data and Liquid Biopsies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04838327
• Other study ID #: 1-10-72-7-21
• Status: Recruiting
• Start date: August 16, 2021
• Est. completion date: April 1, 2026

Study information

• Verified date: July 2023
• Source: Aarhus University Hospital
• Contact: Louise B Callesen, MD
• Phone: +4578462535
• Email: louicall[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A single-arm prospective observational translational study of biomarkers in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal Tract.

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 information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Gastrointestinal Tract
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Response rate	According to RECIST version 1.1	6 months post-treatment
Secondary	Progression Free Survival	Time from inclusion to progression according to RECIST version 1.1	2 years last patient
Secondary	Overall Survival	Time from inclusion til death from any cause	2 years last patient
Secondary	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