Rare Subtypes of Gastrointestinal Cancers

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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer of 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.

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Louise B Callesen, MD; Phone Number: +4578462535; Email: louicall@rm.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Department of Oncology, Aarhus University Hospital
    • Contact: Louise B Callesen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Principal Investigator: Louise B Callesen, MD, Experimental Clinical Oncology

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 1-10-72-7-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No