The GALLOP-11 Study

NCT05178030 | Completed

• 1 other identifier: 201900781
• Study Type: observational
• Target: 243
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Gastro-intestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 years

Secondary Outcomes (5)

• The sensitivity and specificity of the designed KIT exon 11 mutation

  3 years

• Technical validity of the ddPCR assay

  3 years

• Clinical validity of the ddPCR assay

  3 years

• Development of new assays to detect secondary mutations

  3 years

• Determination of time between first detection of secondary mutations and progression

  3 years

Study Arms (1)

GALLOP-11

Patients with a proven KIT exon 11 mutated GIST covered by our in-house designed ddPCR assay.

Other: vena punction

Interventions

vena punction OTHER

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

GALLOP-11

Eligibility Criteria

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

Study Population

The study will be performed in a group of KIT exon 11 detectable (by our ddPCR assay) mutated GIST patients treated according to national guidelines. Newly diagnosed patients will be asked to participate as well as patients that are already on treatment. Furthermore, all GALLOP study patients that have a KIT exon 11 mutation that can be detected by our assay can participate.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Cancer Society: collaborator

Study Sites (5)

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

LUMC

Leiden, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample and/or biopsy

Study Officials

• An KL Reyners, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: January 5, 2022
• Study Start: May 11, 2021
• Primary Completion: January 29, 2024
• Study Completion: September 1, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

NL (5)