Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-06 @ 9:25 PM
Study NCT ID:
NCT02310503
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2014-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spanish Registry of Mohs Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D018223', 'term': 'Dermatofibrosarcoma'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D051677', 'term': 'Histiocytoma, Malignant Fibrous'}, {'id': 'D018294', 'term': 'Neoplasms, Adnexal and Skin Appendage'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D051642', 'term': 'Histiocytoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015580', 'term': 'Mohs Surgery'}], 'ancestors': [{'id': 'D008866', 'term': 'Microsurgery'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D062109', 'term': 'Dermatologic Surgical Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor recurrence', 'timeFrame': '6 years'}], 'secondaryOutcomes': [{'measure': 'Short term outcomes', 'timeFrame': '1 month', 'description': 'Bleeding, infection, abnormal scar, necrosis'}, {'measure': 'Use of resources', 'timeFrame': 'During surgery', 'description': 'Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.'}, {'measure': 'Impairments of body function and structure', 'timeFrame': '6 years', 'description': 'presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mohs Surgery'], 'conditions': ['Skin Neoplasms', 'Carcinoma, Basal Cell', 'Carcinoma, Squamous Cell', 'Dermatofibrosarcoma', 'Melanoma', 'Histiocytoma, Malignant Fibrous', 'Neoplasms, Adnexal and Skin Appendage']}, 'referencesModule': {'references': [{'pmid': '26115794', 'type': 'BACKGROUND', 'citation': "Alonso-Alonso T, Redondo-Bellon P, Sanmartin-Jimenez O, de Eusebio-Murillo E, Garcia-Doval I, Rodriguez-Prieto MA. Census of Centers That Perform Mohs' Micrographic Surgery in Spain and Description of Their Activity: A Feasibility Study for the Mohs' Micrographic Surgery Registry of the Foundation of the Spanish Academy of Dermatology and Venereology. Actas Dermosifiliogr. 2015 Nov;106(9):764-6. doi: 10.1016/j.ad.2015.02.014. Epub 2015 Jun 23. No abstract available. English, Spanish."}, {'pmid': '26028578', 'type': 'BACKGROUND', 'citation': 'Ruiz-Salas V, Garces JR, Minano Medrano R, Alonso-Alonso T, Rodriguez-Prieto MA, Lopez-Estebaranz JL, Sanmartin-Jimenez O, Guillen Barona C, Delgado Jimenez Y, Toll-Abello A, Vargas Diez E, Ciudad Blanco C, Alfaro Rubio A, Allende Markixana I, de Eusebio Murillo E, Manubens-Mercade E, Vazquez-Veiga H, Barchino Ortiz L, Garcia-Doval I, Redondo Bellon P. Description of Patients Undergoing Mohs Surgery in Spain: Initial Report on Data From the Spanish Registry of Mohs Surgery (REGESMOHS). Actas Dermosifiliogr. 2015 Sep;106(7):562-8. doi: 10.1016/j.ad.2015.04.002. Epub 2015 May 28. English, Spanish.'}, {'pmid': '28802488', 'type': 'BACKGROUND', 'citation': 'de Eusebio Murillo E, Martin Fuentes A, Ruiz-Salas V, Garces JR, Minano Medrano R, Lopez-Estebaranz JL, Alonso-Alonso T, Rodriguez-Prieto MA, Delgado Jimenez Y, Morales V, Redondo Bellon P, Manubens-Mercade E, Sanmartin-Jimenez O, Guillen Barona C, Cabeza R, Cano N, Toll-Abello A, Navarro Tejedor R, Artola Igarza JL, Allende Markixana I, Alfaro Rubio A, Ciudad Blanco C, Vazquez-Veiga H, Barchino Ortiz L, Descalzo MA, Garcia-Doval I. Characterization of Surgical Procedures in the Spanish Mohs Surgery Registry (REGESMOHS) for 2013-2015. Actas Dermosifiliogr. 2017 Nov;108(9):836-843. doi: 10.1016/j.ad.2017.04.018. Epub 2017 Aug 9. English, Spanish.'}, {'pmid': '28898467', 'type': 'BACKGROUND', 'citation': 'Camarero-Mulas C, Delgado Jimenez Y, Sanmartin-Jimenez O, Garces JR, Rodriguez-Prieto MA, Alonso-Alonso T, Minano Medrano R, Lopez-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll-Abello A, Artola Igarza JL, Allende Markixana I, Suarez Fernandez R, Alfaro Rubio A, Alonso Pacheco ML, Vazquez-Veiga H, de la Cueva Dobao P, Ruiz-Salas V, Vilarrasa Rull E, Barchino L, Morales-Gordillo V, Ocerin-Guerra I, Navarro Tejedor R, Hueso L, Mayor Arenal M, Seoane-Pose MJ, Cano-Martinez N, Garcia-Doval I, Descalzo MA; REGESMOHS (Registro Espanol de Cirugia de Mohs). Mohs micrographic surgery in the elderly: comparison of tumours, surgery and first-year follow-up in patients younger and older than 80 years old in REGESMOHS. J Eur Acad Dermatol Venereol. 2018 Jan;32(1):108-112. doi: 10.1111/jdv.14586. Epub 2017 Oct 5.'}, {'pmid': '29373111', 'type': 'BACKGROUND', 'citation': 'Ruiz-Salas V, Garces JR, Alonso-Alonso T, Rodriguez-Prieto MA, Toll-Abello A, Eusebio Murillo E, Minano R, Lopez-Estebaranz JL, Sanmartin-Jimenez O, Guillen Barona C, Allende Markixana I, Alfaro Rubio A, Delgado Jimenez Y, Navarro R, Barchino Ortiz L, Lazaro Ochaita P, Vilarasa E, Ciudad Blanco C, Vazquez-Veiga H, Artola Igarza JL, Alonso ML, Garcia-Doval I, Descalzo MA, Redondo Bellon P. Description of patients excluded for Mohs surgery after pre-surgical evaluation: data from the Regesmohs Spanish registry. Actas Dermosifiliogr (Engl Ed). 2018 May;109(4):346-350. doi: 10.1016/j.ad.2017.11.008. Epub 2018 Jan 17. English, Spanish.'}, {'pmid': '30246444', 'type': 'BACKGROUND', 'citation': 'Delgado Jimenez Y, Camarero-Mulas C, Sanmartin-Jimenez O, Garces JR, Rodriguez-Prieto MA, Alonso-Alonso T, Minano Medrano R, Lopez-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll A, Artola Igarza JL, Allende Markixana I, Suarez Fernandez R, Alfaro Rubio A, Alonso Pacheco ML, Vazquez-Veiga H, de la Cueva Dobao P, Ruiz-Salas V, Vilarrasa E, Barchino L, Morales-Gordillo V, Ocerin-Guerra I, Navarro Tejedor R, Hueso L, Mayor Arenal M, Seoane-Pose MJ, Cano-Martinez N, Garcia-Doval I, Descalzo MA; REGESMOHS. Differences of Mohs micrographic surgery in basal cell carcinoma versus squamous cell carcinoma. Int J Dermatol. 2018 Nov;57(11):1375-1381. doi: 10.1111/ijd.14223. Epub 2018 Sep 23.'}], 'seeAlsoLinks': [{'url': 'https://aedv.es/investigacion/proyectos-de-investigacion/registro-nacional-de-cirugia-micrografica-de-mohs/', 'label': 'Updated descrition of the study (in Spanish)'}]}, 'descriptionModule': {'briefSummary': 'REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence.\n\nREGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in participating centers. All consecutive patients are included. The only exclusion criteria are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients considered for Mohs surgery in participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients considered for Mohs surgery\n\nExclusion Criteria:\n\n* Under 18 years-old\n* Legally incompetent'}, 'identificationModule': {'nctId': 'NCT02310503', 'acronym': 'REGESMOHS', 'briefTitle': 'Spanish Registry of Mohs Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Academia Española de Dermatología'}, 'officialTitle': 'Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]', 'orgStudyIdInfo': {'id': 'FAE-MOH-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mohs surgery', 'description': 'Patients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants.', 'interventionNames': ['Procedure: Mohs surgery']}], 'interventions': [{'name': 'Mohs surgery', 'type': 'PROCEDURE', 'description': 'A surgical technique used primarily in the treatment of skin neoplasms, especially basal cell or squamous cell carcinoma of the skin. This procedure is a microscopically controlled excision of cutaneous tumors either after fixation in vivo or after freezing the tissue. Serial examinations of fresh tissue specimens are most frequently done.', 'armGroupLabels': ['Mohs surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Quirón Teknon', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'city': 'León', 'country': 'Spain', 'facility': 'Complejo Asistencial Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clínica Quirón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Zarzuela', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación de Alcorcón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Manises', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Ignacio Garcia-Doval, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Unit. Academia Española de Dermatologia y Venereologia (Spanish Academy of Dermatology)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Academia Española de Dermatología', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}