Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-02-04 @ 12:40 PM
Study NCT ID:
NCT03488706
Status:
UNKNOWN
Last Update Posted:
2018-04-05
First Post:
2018-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-29', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-03-29', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating tumor cells detection', 'timeFrame': 'Prior to prostate biopsy', 'description': 'Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PSA 4.00- 10.99 ng/ml patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are willing to sign the informed consent and agree to comply with the study procedures.\n* Age from 20 to 99 years old\n* Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months\n\nExclusion Criteria:\n\n* Age \\< 20 years\n* Refuse to sign the informed consent form\n* Received regional anesthesia and general anesthesia within one month\n* Previous cancer history\n* Autoimmune diseases\n* Chronic inflammatory diseases\n* Diagnosed with colorectal polyps or adenomas\n* Acute inflammatory or infectious diseases in three months\n* Other diseases decided by PI'}, 'identificationModule': {'nctId': 'NCT03488706', 'briefTitle': 'Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level', 'organization': {'class': 'INDUSTRY', 'fullName': 'CellMaxLife'}, 'officialTitle': 'Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level', 'orgStudyIdInfo': {'id': 'CMx-CTC-PC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gray Zone Group', 'description': 'The gray zone group PSA between 4.00 to 10.99 ng/ml.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ying-Hsu Chang', 'role': 'CONTACT'}], 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'Joy Chang', 'role': 'CONTACT', 'email': 'joy@cellmaxlife.com', 'phone': '+886-2-26558455', 'phoneExt': '404'}], 'overallOfficials': [{'name': 'Ying-Hsu Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CellMaxLife', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}