Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
Study NCT ID:
NCT02280161
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2014-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer
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': 'A blood sample of 30mL or a saliva collection (obtained by spitting into a special collection cup) will be obtained from each patient.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of germ-line variants', 'timeFrame': 'Up to 5 years', 'description': "The prevalence of germ-line variants of interest will be compared to the baseline prevalence found using available large human genomic DNA collections. The primary statistical analysis will involve comparisons of genotypes between with (cases) and without (controls) the germ-line mutation. This analysis will include Pearson's chi-square analysis or Fisher's exact test and computation of odds ratios to assess the relationship of the genetic polymorphism and cancer risk."}, {'measure': 'Overall genotype frequencies', 'timeFrame': 'Up to 5 years', 'description': 'The overall genotype frequencies among the cases and expected control levels will first be compared with the frequencies expected from Hardy-Weinberg equilibrium by goodness-of-fit chi-square. Odds ratios and 95% confidence intervals will be used to estimate risk associated with the variant genotypes by using both univariate and unconditional multivariate logistic regression models.'}, {'measure': 'Response to treatment', 'timeFrame': 'Up to 5 years', 'description': 'The impact of inherited variants on response to treatment will be determined.'}, {'measure': 'Cancer development', 'timeFrame': 'Up to 5 years', 'description': 'The role of inherited variants in clinical and pathological cancer development will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'This research trial studies germ-line mutations in blood and saliva samples from patients with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory may help doctors learn more about how inherited genetic mutations can affect cancer predisposition (an inherited increase in the risk of developing cancer), their impact on treatment response, and their role in cancer development.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.\n\nII. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the effect of the identified variants on tumor micro-ribonucleic acid (miRNA), protein and gene expression.\n\nII. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and without variants of interest to discover correlations between such levels and the presence of cancer and/or response to therapy in these patients.\n\nOUTLINE:\n\nPatients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.\n\nAfter completion of study, patients are followed up for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with a confirmed diagnosis of cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically or clinical confirmed tissue diagnosis of a cancer\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Patients will be excluded if their cancer cannot be confirmed\n* Refusal to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT02280161', 'briefTitle': 'Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'An Investigation of the Role of Germ-Line Mutations in Cancer Predisposition, Tumor Biology, and Response to Treatment', 'orgStudyIdInfo': {'id': '14-001115'}, 'secondaryIdInfos': [{'id': 'NCI-2014-02065', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'JCCCID488', 'type': 'OTHER', 'domain': 'Jonsson Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative (germ-line mutation analysis)', 'description': 'Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.', 'interventionNames': ['Other: cytology specimen collection procedure']}], 'interventions': [{'name': 'cytology specimen collection procedure', 'type': 'OTHER', 'otherNames': ['cytologic sampling'], 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative (germ-line mutation analysis)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanne B. Weidhaas', 'role': 'CONTACT', 'email': 'jweidhaas@mednet.ucla.edu', 'phone': '310-825-9775'}, {'name': 'Joanne B. Weidhaas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Joanne Weidhaas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}