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Trial record 64 of 65 for:    Sarcoma | "Dermatofibroma"

Spanish Registry of Mohs Surgery (REGESMOHS)

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ClinicalTrials.gov Identifier: NCT02310503
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología

Brief Summary:

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.

REGESMOHS 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.


Condition or disease Intervention/treatment
Skin Neoplasms Carcinoma, Basal Cell Carcinoma, Squamous Cell Dermatofibrosarcoma Melanoma Histiocytoma, Malignant Fibrous Neoplasms, Adnexal and Skin Appendage Procedure: Mohs surgery

Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]
Study Start Date : July 2013
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Group/Cohort Intervention/treatment
Mohs surgery
Patients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants.
Procedure: Mohs surgery
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.




Primary Outcome Measures :
  1. Tumor recurrence [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. Short term outcomes [ Time Frame: 1 month ]
    Bleeding, infection, abnormal scar, necrosis

  2. Use of resources [ Time Frame: During surgery ]
    Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.

  3. Impairments of body function and structure [ Time Frame: 6 years ]
    presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients considered for Mohs surgery in participating centers.
Criteria

Inclusion Criteria:

  • All consecutive patients considered for Mohs surgery

Exclusion Criteria:

  • Under 18 years-old
  • Legally incompetent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310503


Contacts
Contact: Ignacio Garcia-Doval, MD, PhD 34-915446284 investigacion@aedv.es
Contact: Pedro Redondo, MD, PhD 34-948255400 ext 4311 predondo@unav.es

Locations
Spain
Hospital Universitario de Cruces Recruiting
Barakaldo, Spain
Contact: Irati Allende Markixana, MD         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Agustí Toll-Abelló, MD         
Hospital Quirón Teknon Recruiting
Barcelona, Spain
Contact: Joan Ramón Garcés, MD         
Sub-Investigator: Elena Manubens.Mercadé, MD         
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Joan Ramon Garcés, MD         
Sub-Investigator: Verónica Ruiz-Salas, MD         
Complejo Hospitalario Universitario de Guadalajara Recruiting
Guadalajara, Spain
Contact: Esther De Eusebio Murillo, MD         
Complejo Asistencial Universitario de León Recruiting
León, Spain
Contact: Teresa Alonso, MD         
Sub-Investigator: Manuel Ángel Rodriguez-Prieto, MD         
Clínica Quirón Recruiting
Madrid, Spain
Contact: Yolanda Delgado Jiménez, MD         
Sub-Investigator: Victoriano Morales-Gordillo, MD         
Hospital de la Princesa Recruiting
Madrid, Spain
Contact: Yolanda Delgado Jiménez, MD         
Sub-Investigator: Erich Vargas Diez, MD         
Hospital Gregorio Marañon Recruiting
Madrid, Spain
Contact: Lucia Barchino Ortiz, MD         
Sub-Investigator: Ricardo Suarez, MD         
Sub-Investigator: Natividad Cano, MD         
Hospital La Zarzuela Recruiting
Madrid, Spain
Contact: Cristina Ciudad Blanco, MD         
Sub-Investigator: Lucia Barchino Ortiz, MD         
Hospital Universitario Fundación de Alcorcón Recruiting
Madrid, Spain
Contact: Román Miñano, MD         
Sub-Investigator: Jose Luis López-Estebaranz, MD         
Sub-Investigator: Lucia Asacanio Armada, MD         
Sub-Investigator: Dolores Caro Gutierrez, MD         
Clínica Universitaria de Navarra Recruiting
Pamplona, Spain
Contact: Pedro Redondo, MD       predondo@unav.es   
Sub-Investigator: Pilar Gil, MD         
Complexo Hospitalario Universitario de Santiago Recruiting
Santiago de Compostela, Spain
Contact: Hugo Vázquez-Veiga, MD         
Sub-Investigator: María José Seoane Pose, MD         
Hospital Manises Recruiting
Valencia, Spain
Contact: Alberto Alfaro Rubio, MD         
Sub-Investigator: Luis Hueso Gabriel, MD         
Sub-Investigator: Antonio Martorell, MD         
Instituto Valenciano de Oncología Recruiting
Valencia, Spain
Contact: Onofre Sanmartín-Jiménez, MD         
Sub-Investigator: Carlos Guillén-Barona, MD         
Sub-Investigator: Carlos Serra Guillen, MD         
Sub-Investigator: Eduardo Nagore Enguidanos, MD         
Sub-Investigator: Beatriz Llombart Cussac, MD         
Sub-Investigator: Celia Requena Caballero, MD         
Sponsors and Collaborators
Fundación Academia Española de Dermatología
Roche Pharma AG
Investigators
Study Director: Ignacio Garcia-Doval, MD, PhD Research Unit. Academia Española de Dermatologia y Venereologia (Spanish Academy of Dermatology)

Additional Information:
Publications of Results:
Camarero-Mulas C, Delgado Jiménez Y, Sanmartín-Jiménez O, Garcés JR, Rodríguez-Prieto MA, Alonso-Alonso T, Miñano Medrano R, López-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll-Abelló A, Artola Igarza JL, Allende Markixana I, Suarez Fernández R, Alfaro Rubio A, Alonso Pacheco ML, Vázquez-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 Español de Cirugía 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.

Other Publications:
Responsible Party: Fundación Academia Española de Dermatología
ClinicalTrials.gov Identifier: NCT02310503     History of Changes
Other Study ID Numbers: FAE-MOH-2013-01
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fundación Academia Española de Dermatología:
Mohs Surgery

Additional relevant MeSH terms:
Histiocytoma
Histiocytoma, Malignant Fibrous
Sarcoma
Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Skin Neoplasms
Carcinoma, Basal Cell
Dermatofibrosarcoma
Neoplasms, Adnexal and Skin Appendage
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Fibrosarcoma