Clinical trial · Observational
The GALLOP-11 Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastro-intestinal Stromal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vena punction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- GALLOP-11
- description
- Patients with a proven KIT exon 11 mutated GIST covered by our in-house designed ddPCR assay.
- interventionNames
- Other: vena punction
Primary outcomes (1)
- measure
- The negative predictive value of the ddPCR assay with regard to KIT exon 11 circulating tumour mutation
- timeFrame
- 3 years
- description
- The negative predictive value of the ddPCR assay with regard to KIT exon 11 circulating tumour mutation digital droplet PCR (ddPCR) assay in relation to CT-scans.
Secondary outcomes (5)
- measure
- The sensitivity and specificity of the designed KIT exon 11 mutation
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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); 2. 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; 3. Age ≥18 years; 4. Written informed consent provided. Exclusion Criteria: 1\. Patients who are unable to comply with study procedures and follow up.
References
Publications (0)
Data not yet available