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Skin NeoplasmsREGESMOHSNCT02310503

Spanish Registry of Mohs Surgery

An observational study of Skin Neoplasms and Carcinoma, Basal Cell, run by Fundación Academia Española de Dermatología at 15 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mohs surgery
Type of treatment
Surgery or procedure
How many people
6,000 participants
Where
15 sitesSpain
Study dates
1 Jul 2013to 29 Feb 2020
How long will I take part?
4 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive patients considered for Mohs surgery in participating centers.

Who may be able to join

  • All consecutive patients considered for Mohs surgery

Who cannot join

  • Under 18 years-old
  • Legally incompetent

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Hospital Universitario de Cruces

    Barakaldo

  • Hospital del Mar

    Barcelona

  • Hospital Quirón Teknon

    Barcelona

  • Hospital Santa Creu i Sant Pau

    Barcelona

  • Complejo Hospitalario Universitario de Guadalajara

    Guadalajara

  • Complejo Asistencial Universitario de León

    León

  • Clínica Quirón

    Madrid

  • Hospital de la Princesa

    Madrid

  • Hospital Gregorio Marañon

    Madrid

  • Hospital La Zarzuela

    Madrid

  • Hospital Universitario Fundación de Alcorcón

    Madrid

  • Clínica Universitaria de Navarra

    Pamplona

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital Manises

    Valencia

  • Instituto Valenciano de Oncología

    Valencia

Other trials in Spain

About this study

Official title: Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]

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.

Being tested
Mohs surgery
Keywords
Mohs Surgery
Medical subject headings
Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Dermatofibrosarcoma, Melanoma, Histiocytoma, Malignant Fibrous, Neoplasms, Adnexal and Skin Appendage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mohs surgeryProcedure or 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.

Study groups in NCT02310503
Study groupRoleWhat they receive
Mohs surgeryPatients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants.
Receives: Procedure: Mohs surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor recurrence

    Measured: 6 years

Secondary outcomes (3)

  1. Short term outcomes

    Bleeding, infection, abnormal scar, necrosis

    Measured: 1 month

  2. Use of resources

    Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.

    Measured: During surgery

  3. Impairments of body function and structure

    presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2014 (estimated)
  2. Study start1 Jul 2013
  3. Primary completion29 Feb 2020
  4. Study completion29 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (actual)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02310503
Sponsor's protocol ID
FAE-MOH-2013-01
Acronym
REGESMOHS
Status last verified
May 2020
First submitted
1 Dec 2014
Last updated
5 May 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26115794

  • 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.

    PubMed 26028578

  • 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.

    PubMed 28802488

  • 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.

    PubMed 28898467

  • 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.

    PubMed 29373111

  • 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.

    PubMed 30246444

Questions about this trial

What is this clinical trial studying?

An observational study of Skin Neoplasms and Carcinoma, Basal Cell, run by Fundación Academia Española de Dermatología at 15 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor recurrence (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02310503, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.

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