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NCT Number: NCT04838327

Rare Subtypes of Gastrointestinal Cancers

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

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Key information

Conditions

Cancer of Gastrointestinal Tract Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location status: Recruiting

Location contact

Louise B Callesen, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility and translational analysis

    Time frame: 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 outcomes

  1. Response rate

    Time frame: 6 months post-treatment

    According to RECIST version 1.1

  2. Progression Free Survival

    Time frame: 2 years last patient

    Time from inclusion to progression according to RECIST version 1.1

  3. Overall Survival

    Time frame: 2 years last patient

    Time from inclusion til death from any cause

  4. Quality of Life by EORTC QLQ-C30

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Louise B Callesen, MD

CONTACT

[email protected]

+4578462535

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2021
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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