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The GALLOP-11 Study

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ClinicalTrials.gov Identifier: NCT05178030
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
A.K.L. Reyners, University Medical Center Groningen

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.

Condition or disease Intervention/treatment
Gastro-intestinal Stromal Tumors Other: vena punction

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
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : September 2024


Group/Cohort Intervention/treatment
GALLOP-11
Patients with a proven KIT exon 11 mutated GIST covered by our in-house designed ddPCR assay.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The sensitivity and specificity of the designed KIT exon 11 mutation [ Time Frame: 3 years ]
    To establish the sensitivity and specificity of the designed KIT exon 11 mutation ddPCR assay

  2. Technical validity of the ddPCR assay [ Time Frame: 3 years ]
    The detection of ctDNA expressed in copies/mL and fractional abundance, assessed by the designed KIT exon 11 circulating tumour mutation digital droplet PCR (ddPCR) assay, in different laboratories, and by Agena Bioscience, will be assessed.

  3. Clinical validity of the ddPCR assay [ Time Frame: 3 years ]
    The first detection of increase in the level of the primary KIT exon 11 mutation in ctDNA determined in time to progression seen on standard radiological evaluation by CT-scan based on RECIST 1.1

  4. Development of new assays to detect secondary mutations [ Time Frame: 3 years ]
    Based on mutation analysis of tumor biopsies of patients with progressive disease, ctDNA assays will be designed and tested

  5. Determination of time between first detection of secondary mutations and progression [ Time Frame: 3 years ]
    Based on progression of disease on CT, we will analyze ctDNA of patients to determine wether secondary mutations could be found before radiologic progression


Biospecimen Retention:   Samples Without DNA
Blood sample and/or biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05178030


Contacts
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Contact: An KL Reyners, MD, PhD +31 50 361 1543 a.k.l.reyners@umcg.nl

Locations
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Netherlands
Netherlands Cancer Institute Not yet recruiting
Amsterdam, Netherlands
Contact: N. Steeghs, MD, PhD         
Principal Investigator: N. Steeghs, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: A. K.L. Reyners, MD, PhD    +31 50 361 6161    a.k.l.reyners@umcg.nl   
Contact: R. Bleckman, MD    +31 50 361 6161      
Principal Investigator: A. K.L. Reyners, MD, PhD         
LUMC Not yet recruiting
Leiden, Netherlands
Contact: A. J Gelderblom, MD, PhD         
Principal Investigator: A J Gelderblom, MD, PhD         
Radboud UMC Not yet recruiting
Nijmegen, Netherlands
Contact: I. Desar, MD, PhD         
Principal Investigator: I. Desar, MD, PhD         
Erasmus MC Not yet recruiting
Rotterdam, Netherlands
Contact: R HJ Mathijssen, MD, PhD         
Principal Investigator: R HJ Mathijssen, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Dutch Cancer Society
Investigators
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Principal Investigator: An KL Reyners, MD, PhD Principal Investigator
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Responsible Party: A.K.L. Reyners, Coordinating investigator/project leader, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT05178030    
Other Study ID Numbers: 201900781
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases