Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-30 @ 4:53 PM
Study NCT ID:
NCT01444560
Status:
COMPLETED
Last Update Posted:
2012-10-16
First Post:
2011-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009506', 'term': 'Nevus'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'human skin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-15', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-09-29', 'lastUpdatePostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cutaneous Melanoma', 'Nevi']}, 'referencesModule': {'references': [{'pmid': '22706980', 'type': 'RESULT', 'citation': 'Sand M, Skrygan M, Georgas D, Sand D, Gambichler T, Altmeyer P, Bechara FG. The miRNA machinery in primary cutaneous malignant melanoma, cutaneous malignant melanoma metastases and benign melanocytic nevi. Cell Tissue Res. 2012 Oct;350(1):119-26. doi: 10.1007/s00441-012-1446-0. Epub 2012 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of miRNA machinery components such as miRNA maturation and transport factors, microprocessor complex and RISC subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.', 'detailedDescription': 'Patients with cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi were included in the study. Punch biopsies were harvested from the center of the tumors. The miRNA machinery components were detected by quantitative real-time reverse transcriptase polymerase chain reaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cutaneous melanoma, cutaneous melanoma metastases, benign melanocytic nevi', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cutaneous melanoma\n* cutaneous melanoma metastases\n* benign melanocytic nevi\n\nExclusion Criteria:\n\n* other forms of malignancy'}, 'identificationModule': {'nctId': 'NCT01444560', 'briefTitle': 'miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'The miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi', 'orgStudyIdInfo': {'id': 'microRNA4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cutaneous Melanoma'}, {'label': 'Cutaneous Melanoma Metastases'}, {'label': 'Benign Melanocytic Nevi'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44791', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Falk G Bechara, PD Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc', 'investigatorFullName': 'Michael Sand', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}