A Comprehensive, Multinational GIST Registry

NCT07273045 | Not Yet Recruiting DMC

• 1 other identifier: reGISTTry
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with a gastrointestinal stromal tumor (GIST), a rare type of tumor in the digestive tractparticipate in this scientific research study, known as a registry study, to help improve understanding and treatment of GIST. This study collects medical information and biological samples-such as blood or tumor tissue-from patients. It does not involve new treatments, medications, or medical procedures. The patient's regular medical care will continue as usual, and participation will not require extra appointments or tests. The study aims to learn more about how GIST behaves, especially in rare forms such as SDH-deficient or NF1-associated tumors. While targeted drugs are available for many patients, some tumors return or become resistant to treatment. By gathering data from many patients, researchers hope to better understand these challenges, identify risk factors for worse outcomes, and help design future studies and treatments-especially for rare types of GIST. If the patient agrees to participate, information will be collected from their medical records, scans (such as CT or MRI), and doctor visits. They may be asked to complete optional questionnaires about their health and quality of life. If they consent, small blood samples (up to 50 ml) may be collected during routine check-ups. If surgery is needed, a small part of the tumor tissue may be stored for research. Other samples-such as saliva, stool, urine, or spinal fluid-may also be collected if they are taken during normal care, to study how bacteria in the body might affect the disease and treatment. Participation is completely voluntary. The patient can choose to join or not, and can withdraw at any time without affecting their care or relationship with their doctor. Even if they do not agree to provide biological samples, they can still take part in the study by sharing medical data and scan results.

Conditions

GIST - Gastrointestinal Stromal Tumor; Gastrointenstinal Stromal Tumor (GIST)

Keywords

GIST; KIT; SDH-Deficiency; NF1; register

Outcome Measures

Primary Outcomes (1)

• Creation of a prospective and retrospective, multi-center, international GIST cohort as a foundation for analyzing prognostic factors and planning future clinical trials.

  30 years

Secondary Outcomes (4)

• Establishment of a comprehensive biobank with corresponding clinical, radiological, and histological data to support future research projects.

  30 years

• Identification of risk factors relevant to the treatment and counseling of GIST patients.

  30 years

• Identification of predictive factors for response to local and systemic therapies.

  30 years

• Characterization of resistance mechanisms.

  30 years

Study Arms (1)

all patients with GIST regardless of disease status or molecular subtype

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of any age group with a diagnosis of gastrointestinal stromal tumor (GIST).

You may qualify if:

• Diagnosis of a gastrointestinal stromal tumor (GIST)
• Verbal and written informed consent for participation in the study with planned prospective data collection
• Physical and mental ability to provide informed consent

You may not qualify if:

• Severe neurological or psychological illness that impairs the ability to give informed consent

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

University Hospital Essem

Essen, North Rhine-Westphalia, 45147, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

During clinical routine procedures, in indicated * Blood * Tumor * Saliva * Stool * Urine * Liquor

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Johanna Falkenhorst, MD

CONTACT

+40 201 723 2011; johanna.falkenhorst@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2056
• Study Completion (Estimated): January 1, 2056
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

DE (1)