Validation of mutation analysis in circulating tumor DNA with a ddPCR assay as diagnostic and follow-up tool for patients with a KIT exon 11 mutated GIST: GALLOP-11

Completed

• Conditions: gastro-intestinal stromal tumors; 10027655

• Registration Number: NL-OMON52793
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

1. Patients with GIST with a by biopsy confirmed primary KIT exon 11 mutation
covered by our KIT exon 11 ddPCR assay (mutation/deletion within target
sequence of c.1665 to c.1736);
2. Patients with an indication for at least 4 CT-scans (and/or MRI scans)
concomitant with regular laboratory examination in a neoadjuvant, adjuvant
and/or palliative care trajectory within the time frame of the study;
3. Age >=18 years;
4. Written informed consent provided.

Exclusion Criteria

1. Patients who are unable to comply with study procedures and follow up.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The NPV of the previously developed KIT exon 11 ddPCR assay in relation to<br /><br>response assessment by CT-scan (and/or MRI scan). The study is considered<br /><br>positive once the NPV is higher than 90%. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>