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Rare Subtypes of Gastrointestinal Cancers

Sponsor
Aarhus University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04838327
Collaborator
(none)
130
Enrollment
1
Location
55.5
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Rare Subtypes of Gastrointestinal Cancers - Real-world Data and Liquid Biopsies
    Actual Study Start Date :
    Aug 16, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility and translational analysis [2 years last patient]

      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.

    Secondary Outcome Measures

    1. Response rate [6 months post-treatment]

      According to RECIST version 1.1

    2. Progression Free Survival [2 years last patient]

      Time from inclusion to progression according to RECIST version 1.1

    3. Overall Survival [2 years last patient]

      Time from inclusion til death from any cause

    4. Quality of Life by EORTC QLQ-C30 [2 years last patient]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Oncology, Aarhus University Hospital Aarhus N Denmark 8200

    Sponsors and Collaborators

    • Aarhus University Hospital

    Investigators

    • Principal Investigator: Louise B Callesen, MD, Experimental Clinical Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Louise Bach Callesen, MD, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT04838327
    Other Study ID Numbers:
    • 1-10-72-7-21
    First Posted:
    Apr 9, 2021
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastrointestinal Neoplasms

    Study Results

    No Results Posted as of Feb 15, 2022