Rare Subtypes of Gastrointestinal Cancers

NCT ID: NCT04838327

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-16

Study Completion Date

2026-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer of Gastrointestinal Tract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Louise Bach Callesen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise B Callesen, MD

Role: PRINCIPAL_INVESTIGATOR

Experimental Clinical Oncology

Locations

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Department of Oncology, Aarhus University Hospital

Aarhus N, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Louise B Callesen, MD

Role: CONTACT

+4578462535

Facility Contacts

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Louise B Callesen, MD

Role: primary

Other Identifiers

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1-10-72-7-21

Identifier Type: -

Identifier Source: org_study_id

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