The GALLOP-11 Study
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ClinicalTrials.gov Identifier: NCT05178030 |
Recruitment Status :
Recruiting
First Posted : January 5, 2022
Last Update Posted : October 11, 2023
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Tracking Information | |||||
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First Submitted Date | May 4, 2021 | ||||
First Posted Date | January 5, 2022 | ||||
Last Update Posted Date | October 11, 2023 | ||||
Actual Study Start Date | May 11, 2021 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
The negative predictive value of the ddPCR assay with regard to KIT exon 11 circulating tumour mutation [ Time Frame: 3 years ] 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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | The GALLOP-11 Study | ||||
Official Title | 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 | ||||
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. | ||||
Detailed Description | This is an observational, non-interventional, multicenter study. The study will be performed within the Dutch GIST consortium (NKI-AvL, Erasmus MC, Radboud UMC, LUMC and UMCG). Patients diagnosed with GIST with a KIT exon 11 mutations that can be detected by our ddPCR assay are eligible. In this way we will study a homogenous patient population with GIST that (usually) responds very well to initial TKI treatment. Therefore, the KIT mutation status must be known. Patients can enter the study at any time point of their disease trajectory. Patients included in GALLOP-11 will have follow-up as described in the European Society of Medical Oncology and Dutch guidelines but with blood draws for ctDNA assessment at similar time points. The primary objective is the negative predictive value (NPV) of the ddPCR assay result in relation to the results of the CT-scan and/or MRI scan (according to RECIST 1.1) at the same time point. Concordance of these results will be determined, from which the negative predictive value (NPV) of our ddPCR assay will be calculated. This is considered the most important value, as the most harmful scenario would be to miss progressive disease because not seen on ctDNA while it could have been seen on CT (and/or MRI). That would mean that ctDNA analysis is not reliable enough to replace CT-scan (and/or MRI) follow-up in the future. To determine the negative predictive value, at least 250 patients need to have an evaluable follow-up strategy. To pursue a solid follow-up period within an achievable timeline, patients with at least four ctDNA measurements, accompanied by a CT-scan (and/or MRI scan), will be considered evaluable for the NPV analysis. Patients who have progression within four scans are always evaluable, since a positive outcome outweighs negative outcomes because it is known that ctDNA should have had measured change once it is seen on CT-scans (and/or MRI scans). |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description: Blood sample and/or biopsy
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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. | ||||
Condition | Gastro-intestinal Stromal Tumors | ||||
Intervention | Other: vena punction
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
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Study Groups/Cohorts | GALLOP-11
Patients with a proven KIT exon 11 mutated GIST covered by our in-house designed ddPCR assay.
Intervention: Other: vena punction
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
250 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 2024 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: 1. Patients who are unable to comply with study procedures and follow up. |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT05178030 | ||||
Other Study ID Numbers | 201900781 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | A.K.L. Reyners, University Medical Center Groningen | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | University Medical Center Groningen | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Dutch Cancer Society | ||||
Investigators |
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PRS Account | University Medical Center Groningen | ||||
Verification Date | October 2023 |