NCT04838327

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

3.6 years

First QC Date

April 1, 2021

Last Update Submit

August 6, 2024

Conditions

Cancer of Gastrointestinal Tract

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Response rate

    6 months post-treatment

  • Progression Free Survival

    2 years last patient

  • Overall Survival

    2 years last patient

  • Quality of Life by EORTC QLQ-C30

    2 years last patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Conditions precluding translational blood sampling
  • Another concomitant cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Louise B Callesen, MD

    Experimental Clinical Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise B Callesen, MD

CONTACT

+4578462535louicall@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 9, 2021

Study Start

August 16, 2021

Primary Completion

April 1, 2025

Study Completion

April 1, 2026

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)