Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-06 @ 10:19 PM
Study NCT ID:
NCT04300361
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2020-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Novel Variants in the DPYD Gene in Patients of Non-Western Descent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. blood sample (whole blood) of 4 ml (EDTA-tube) for sequencing of the DPYD gene\n2. blood samples (whole blood) of 6 ml (EDTA-tubes) each for determination of the DPD enzyme activity'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of variants of the DPYD gene that are possibly associated with an increased risk of severe fluoropyrimidine-related toxicity in patients of non-Western descent', 'timeFrame': 'Patients will be followed for the first 2 cycles (each cycle is 28 days).'}], 'secondaryOutcomes': [{'measure': 'DPD enzyme activity of patients carrying a novel DPYD variant compared to wildtype patients measured in peripheral blood mononuclear cells (PBMCs)', 'timeFrame': 'Through study completion, an average of 2 years'}, {'measure': 'Ability of the DPYD-varifier to predict if a novel DPYD variant is deleterious', 'timeFrame': 'Through study completion, an average of 2 years'}, {'measure': 'Frequency of DPYD variants per ethnic origin', 'timeFrame': 'Through study completion, an average of 2 years'}, {'measure': 'Correlation between genetic variants in genes other than DPYD and fluoropyrimidine-related toxicity', 'timeFrame': 'Through study completion, an average of 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluoropyrimidines', 'DPYD', 'Genotyping', 'Capecitabine', '5-Fluorouracil', '5-FU', 'Non-Western'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a observational, multicenter study to identify novel variants of the DPYD gene which are possible deleterious in patients of non-Western descent.', 'detailedDescription': 'Research has shown that DPYD-guided dose-individualization based on 4 DPYD variants (DPYD\\*2A, c.1236G\\>A, c.2846A\\>T and c.1679T\\>G) can significantly reduce severe fluoropyrimidine-related toxicity. However, these 4 variants are most likely not predictive for toxicity in patients of non-Western descent. In this study the DPYD gene of patients of non-Western descent will be sequenced to identify novel variants that could be associated with a reduced DPD enzyme activity and an increased risk of developing severe fluoropyrimdine-related toxicity. Additionally, the ability to predict if a DPYD variant is possibly deleterious by a recombinant model systen (DPYD-varifier) will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-western patients with an indication for treatment with fluoropyrimidine-based chemotherapy. A patient is classified as non-Western if 1 of the parents or \\> 2 of the grandparents are of non-Western descent.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest\n* Patients need to be self-declared non-Western\n* Age 18 years and older\n* Able and willing to give written informed consent\n* WHO performance status of 0, 1 or 2\n* Life expectancy of at least 12 weeks\n* Able and willing to undergo blood sampling for study related analysis\n* Adequate baseline patient characteristics (complete blood count, hepatic function which involves serum bilirubin, ASAT, ALAT, and renal function)\n\nExclusion Criteria:\n\n* Prior treatment with fluoropyrimidines\n* Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety"}, 'identificationModule': {'nctId': 'NCT04300361', 'acronym': 'DPYD-NOW', 'briefTitle': 'Identifying Novel Variants in the DPYD Gene in Patients of Non-Western Descent', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'A Prospective, Multicenter, Observational Study to Identify Novel Deleterious Variants in the DPYD Gene in Patients of Non-Western Descent: The DPYD-NOW Study', 'orgStudyIdInfo': {'id': 'DPNOW'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Western patients', 'description': 'Patients of non-Western descent with an indication for treatment with fluoropyrimidine-based chemotherapy. A patient is classified as non-Western if a one (1) of the parents or more than two (\\>2) of the grand parents are of non-Western descent.', 'interventionNames': ['Genetic: Sequencing of DPYD gene']}], 'interventions': [{'name': 'Sequencing of DPYD gene', 'type': 'GENETIC', 'description': 'The DPYD gene of non-Western patients will be sequenced to identify DPYD variants that are possibly associated with an increased risk of developing severe fluoropyrimidine-related toxicity.', 'armGroupLabels': ['Non-Western patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hans Gelderblom, Prof.', 'role': 'CONTACT', 'email': 'a.j.gelderblom@lumc.nl', 'phone': '+31 (0)71 - 526 9111'}, {'name': 'Jesse Swen, PhD', 'role': 'CONTACT', 'email': 'j.j.swen@lumc.nl', 'phone': '+31 (0)71 - 5262790'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Haga Hospital', 'class': 'OTHER'}, {'name': 'Medical Center Haaglanden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'HansGelderblom', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}