CompletedNot Applicable

The GALLOP-11 Study

Netherlands243 participantsStarted 2021-05-11

Plain-language summary

An observational, multicenter study will be performed. Regular 3-12 monthly follow-up by CT-scan will be compared to results of ctDNA analysis. Blood for analysis of mutation in ctDNA will be collected at the same moment a CT-scan is performed. All samples will be analyzed at the reference Pathology laboratory at the UMCG. A part of the samples will also be analyzed in other institutions to implement the ddPCR. Primary endpoint is concordance between CT-scan and ctDNA analysis results, from which the negative predictive value (NPV) of our ddPCR assay will be calculated.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with GIST with a biopsy confirmed primary KIT exon 11 mutation covered by our KIT exon 11 ddPCR assay (mutation/deletion within target sequence of c.1665\_1736);
✓. Patients with an indication for at least 4 CT-scans concomitant with regular laboratory examination in a neoadjuvant, adjuvant and/or palliative care trajectory within the time frame of the study;
✓. Age ≥18 years;
✓. Written informed consent provided.

What they're measuring

The negative predictive value of the ddPCR assay with regard to KIT exon 11 circulating tumour mutation

Timeframe: 3 years

Trial details

NCT IDNCT05178030

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-29

View on ClinicalTrials.gov More Gastro-intestinal Stromal Tumors trials