Actively Recruiting

Age: 18Years +
All Genders
NCT07522762

Long-term Survivorship Challenges of Advanced/Metastatic GIST Patients Responding to Tyrosine Kinase Inhibitor Treatment: an Observational Study

Led by The Netherlands Cancer Institute · Updated on 2026-04-13

330

Participants Needed

1

Research Sites

626 weeks

Total Duration

On this page

Sponsors

T

The Netherlands Cancer Institute

Lead Sponsor

E

European Organisation for Research and Treatment of Cancer - EORTC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Gastrointestinal stromal tumours (GISTs) are rare malignancies arising along the gastrointestinal tract. Tyrosine kinase inhibitors (TKIs) have substantially improved survival for patients with unresectable or metastatic GIST. As a result, an increasing number of patients live with advanced disease under chronic TKI therapy, highlighting the need to understand long-term survivorship, including health-related quality of life (HRQoL), treatment burden, and clinical outcomes. This international, multicentre observational study includes two components: a retrospective cross-sectional study to evaluate the relevance and applicability of patient-reported outcome instruments, and a prospective cohort to document long-term clinical outcomes, HRQoL, treatment patterns, and survivorship challenges. Participants will include adults with advanced or metastatic GIST who have received TKI therapy for at least 2 years. Data will be collected from medical records and through validated patient-reported outcome questionnaires at baseline and annually for up to 10 years. This study aims to provide insight into HRQoL problems, treatment discontinuation, coping strategies, and the impact of financial toxicity among long-term survivors of GIST.

CONDITIONS

Official Title

Long-term Survivorship Challenges of Advanced/Metastatic GIST Patients Responding to Tyrosine Kinase Inhibitor Treatment: an Observational Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older (no upper age limit)
  • Advanced or metastatic GIST with histologically confirmed diagnosis
  • Receiving TKI treatment (e.g., sunitinib, regorafenib, avapritinib, ripretinib) for at least 2 years
  • Current TKI treatment ongoing; interruptions up to 3 months allowed
  • Able to read and complete questionnaires
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Receiving TKI treatment only in an adjuvant setting
  • Psychological, familial, sociological, or geographical conditions that may interfere with study compliance and follow-up
  • Too ill with imminent risk of death as judged by healthcare professional

AI-Screening

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Trial Site Locations

Total: 1 location

1

Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands, 1066 CX

Actively Recruiting

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Research Team

T

Tessa van Amerongen, MSc, Drs.

CONTACT

O

Olga Husson, Dr., Associate professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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