Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT02964351
Status:
UNKNOWN
Last Update Posted:
2016-11-16
First Post:
2016-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
microRNA Profiles Identification in Adeno Carcinoma Prostate Cancer
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'MicroRNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metastasis size and location', 'timeFrame': '18 months', 'description': 'Location of metastasis by a report analyzing the pathological examination (PET-MR output).'}], 'secondaryOutcomes': [{'measure': 'MicroRNA profile by using Nano-string technology validated by real time PCR', 'timeFrame': '24 months', 'description': 'Validation of MicroRNA pattern by using real time PCR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MicroRNA', 'Prostate Carcinoma', 'PET-MR'], 'conditions': ['Prostate Carcinosarcoma']}, 'referencesModule': {'references': [{'pmid': '25104502', 'type': 'BACKGROUND', 'citation': 'Berindan-Neagoe I, Monroig Pdel C, Pasculli B, Calin GA. MicroRNAome genome: a treasure for cancer diagnosis and therapy. CA Cancer J Clin. 2014 Sep-Oct;64(5):311-36. doi: 10.3322/caac.21244. Epub 2014 Aug 7.'}, {'pmid': '18325358', 'type': 'BACKGROUND', 'citation': 'Hovels AM, Heesakkers RA, Adang EM, Jager GJ, Strum S, Hoogeveen YL, Severens JL, Barentsz JO. The diagnostic accuracy of CT and MRI in the staging of pelvic lymph nodes in patients with prostate cancer: a meta-analysis. Clin Radiol. 2008 Apr;63(4):387-95. doi: 10.1016/j.crad.2007.05.022. Epub 2008 Feb 4.'}, {'pmid': '22099610', 'type': 'BACKGROUND', 'citation': 'Briganti A, Abdollah F, Nini A, Suardi N, Gallina A, Capitanio U, Bianchi M, Tutolo M, Passoni NM, Salonia A, Colombo R, Freschi M, Rigatti P, Montorsi F. Performance characteristics of computed tomography in detecting lymph node metastases in contemporary patients with prostate cancer treated with extended pelvic lymph node dissection. Eur Urol. 2012 Jun;61(6):1132-8. doi: 10.1016/j.eururo.2011.11.008. Epub 2011 Nov 12.'}, {'pmid': '21593787', 'type': 'BACKGROUND', 'citation': 'Weilbaecher KN, Guise TA, McCauley LK. Cancer to bone: a fatal attraction. Nat Rev Cancer. 2011 Jun;11(6):411-25. doi: 10.1038/nrc3055. Epub 2011 May 19.'}, {'pmid': '15630412', 'type': 'BACKGROUND', 'citation': 'Logothetis CJ, Lin SH. Osteoblasts in prostate cancer metastasis to bone. Nat Rev Cancer. 2005 Jan;5(1):21-8. doi: 10.1038/nrc1528.'}, {'pmid': '24072344', 'type': 'BACKGROUND', 'citation': 'Afshar-Oromieh A, Zechmann CM, Malcher A, Eder M, Eisenhut M, Linhart HG, Holland-Letz T, Hadaschik BA, Giesel FL, Debus J, Haberkorn U. Comparison of PET imaging with a (68)Ga-labelled PSMA ligand and (18)F-choline-based PET/CT for the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2014 Jan;41(1):11-20. doi: 10.1007/s00259-013-2525-5. Epub 2013 Sep 27.'}, {'pmid': '15858102', 'type': 'BACKGROUND', 'citation': 'Schmid DT, John H, Zweifel R, Cservenyak T, Westera G, Goerres GW, von Schulthess GK, Hany TF. Fluorocholine PET/CT in patients with prostate cancer: initial experience. Radiology. 2005 May;235(2):623-8. doi: 10.1148/radiol.2352040494.'}]}, 'descriptionModule': {'briefSummary': 'In our study, the investigators want to find correlation between circulating miRNAs associated with prostate cancer metastases to bones and to lymph nodes separately with results of 68Ga-PSMA ligand PET (positron emission computed) imaging.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with high PSA levels', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proven Adeno-carcinoma\n* Underwent prostatectomy and still present high PSA levels\n* Refered to PSMA exam.\n\nExclusion Criteria:\n\n* Below 18 years old\n* HIV/HBV (hepatitis B virus)/HCV (hepatitis C virus) positive\n* Additional malignancy during the past five years.'}, 'identificationModule': {'nctId': 'NCT02964351', 'briefTitle': 'microRNA Profiles Identification in Adeno Carcinoma Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Medical Center'}, 'orgStudyIdInfo': {'id': '0093-16-ASMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High PSA (prostate-specific antigen) levels', 'interventionNames': ['Biological: High PSA levels']}], 'interventions': [{'name': 'High PSA levels', 'type': 'BIOLOGICAL', 'armGroupLabels': ['High PSA (prostate-specific antigen) levels']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Natalia Goldberg, MD', 'role': 'CONTACT', 'email': 'natalia.goldberg@gmail.com', 'phone': '972547833789'}], 'overallOfficials': [{'name': 'Natalia Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuta Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Natalia Goldberg', 'investigatorAffiliation': 'Assuta Medical Center'}}}}