NCT02310503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

6.7 years

First QC Date

December 1, 2014

Last Update Submit

May 4, 2020

Conditions

Skin NeoplasmsCarcinoma, Basal CellCarcinoma, Squamous CellDermatofibrosarcomaMelanomaHistiocytoma, Malignant FibrousNeoplasms, Adnexal and Skin Appendage

Keywords

Mohs Surgery

Outcome Measures

Primary Outcomes (1)

  • Tumor recurrence

    6 years

Secondary Outcomes (3)

  • Short term outcomes

    1 month

  • Use of resources

    During surgery

  • Impairments of body function and structure

    6 years

Study Arms (1)

Mohs surgery

Patients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants.

Procedure: Mohs surgery

Interventions

Mohs surgeryPROCEDURE

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.

Mohs surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients considered for Mohs surgery in participating centers.

You may qualify if:

  • All consecutive patients considered for Mohs surgery

You may not qualify if:

  • Under 18 years-old
  • Legally incompetent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital Universitario de Cruces

Barakaldo, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Quirón Teknon

Barcelona, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Location

Complejo Hospitalario Universitario de Guadalajara

Guadalajara, Spain

Location

Complejo Asistencial Universitario de León

León, Spain

Location

Clínica Quirón

Madrid, Spain

Location

Hospital de la Princesa

Madrid, Spain

Location

Hospital Gregorio Marañon

Madrid, Spain

Location

Hospital La Zarzuela

Madrid, Spain

Location

Hospital Universitario Fundación de Alcorcón

Madrid, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Manises

Valencia, Spain

Location

Instituto Valenciano de Oncología

Valencia, Spain

Location

Related Publications (6)

  • 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: 26115794BACKGROUND

  • 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: 26028578BACKGROUND

  • 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: 28802488BACKGROUND

  • 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: 28898467BACKGROUND

  • 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: 29373111BACKGROUND

  • 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.

    PMID: 30246444BACKGROUND

Related Links

MeSH Terms

Conditions

Skin NeoplasmsCarcinoma, Basal CellCarcinoma, Squamous CellDermatofibrosarcomaMelanomaHistiocytoma, Malignant FibrousNeoplasms, Adnexal and Skin Appendage

Interventions

Mohs Surgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal CellNeoplasms, Squamous CellFibrosarcomaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasHistiocytoma

Intervention Hierarchy (Ancestors)

MicrosurgerySurgical Procedures, OperativeDermatologic Surgical ProceduresPlastic Surgery Procedures

Study Officials

  • Ignacio Garcia-Doval, MD, PhD

    Research Unit. Academia Española de Dermatologia y Venereologia (Spanish Academy of Dermatology)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 8, 2014

Study Start

July 1, 2013

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(15)