Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT03494803
Status:
WITHDRAWN
Last Update Posted:
2023-12-22
First Post:
2018-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No participants enrolled, leading to insufficient patient numbers to initiate the clinical trial.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate cancer', 'timeFrame': '6 months to 1 year', 'description': 'We will develop the linear model and a threshold value differentiating breast cancer from control based on the 100 patient training set. The model will be provided to the researchers:\n\nMethylation score=CG1\\*b1+CG2\\*b2+ CG3\\*b3 + e\n\nCG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept.\n\nWe will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. We will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as prostate cancer or not.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Adenocarcinoma', 'Prostate Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'Prostate cancer is a leading cause of mortality and morbidity.\n\nThe purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in prostate cancer patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be assigned an ID that will be kept confidential according to hospital regulations. IDs will be randomized so that identity will not be revealed except to the approved hospital personnel. Methylation data will be returned to the hospital for follow up of progression of disease and for assessing early prediction of progression of Prostate cancer and will be entered into the data base. Other clinical follow up data will be entered into the electronic data base. All data will be captured in case report form', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff\n\nExclusion Criteria:\n\n* Pregnant women\n* Minors (subjects less than 18 years of age)\n* Prisoners\n* Patients having other than one cancer\n* Subjects unable to consent for themselves\n* Symptomatic of acute prostatitis'}, 'identificationModule': {'nctId': 'NCT03494803', 'briefTitle': 'Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC', 'organization': {'class': 'INDUSTRY', 'fullName': 'HKGepitherapeutics'}, 'officialTitle': 'Clinical Trials on Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells', 'orgStudyIdInfo': {'id': 'HKG-KZ-PRAD-103'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control'}, {'label': 'Prostate Cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Kazakh Institute of Oncology and Radiology', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HKGepitherapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kazakh Research Institute of Oncology & Radiology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}