Spanish Registry of Mohs Surgery NCT02310503

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT02310503
Other study ID #	FAE-MOH-2013-01
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	July 1, 2013
Est. completion date	February 29, 2020

Study information
Verified date	May 2020
Source	Fundación Academia Española de Dermatología
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status	Completed
Enrollment	6000
Est. completion date	February 29, 2020
Est. primary completion date	February 29, 2020
Accepts healthy volunteers	No
Gender	Female
Age group	18 Years and older
Eligibility	Inclusion Criteria: - All consecutive patients considered for Mohs surgery Exclusion Criteria: - Under 18 years-old - Legally incompetent

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country	Name	City
Spain	Hospital Universitario de Cruces	Barakaldo
Spain	Hospital del Mar	Barcelona
Spain	Hospital Quirón Teknon	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Complejo Hospitalario Universitario de Guadalajara	Guadalajara
Spain	Complejo Asistencial Universitario de León	León
Spain	Clínica Quirón	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Gregorio Marañon	Madrid
Spain	Hospital La Zarzuela	Madrid
Spain	Hospital Universitario Fundación de Alcorcón	Madrid
Spain	Clínica Universitaria de Navarra	Pamplona
Spain	Complexo Hospitalario Universitario de Santiago	Santiago de Compostela
Spain	Hospital Manises	Valencia
Spain	Instituto Valenciano de Oncología	Valencia

Sponsors *(2)*
Lead Sponsor	Collaborator
Fundación Academia Española de Dermatología	Roche Pharma AG

Country where clinical trial is conducted

Spain,

References & Publications (6)

Alonso-Alonso T, Redondo-Bellon P, Sanmartín-Jiménez O, de Eusebio-Murillo E, García-Doval I, Rodríguez-Prieto MÁ. 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. English, Spanish. — View Citation

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. — View Citation

de Eusebio Murillo E, Martín Fuentes A, Ruiz-Salas V, Garcés JR, Miñano Medrano R, López-Estebaranz JL, Alonso-Alonso T, Rodríguez-Prieto MÁ, Delgado Jiménez Y, Morales V, Redondo Bellón P, Manubens-Mercadé E, Sanmartín-Jiménez O, Guillén Barona C, Cabeza R, Cano N, Toll-Abelló A, Navarro Tejedor R, Artola Igarza JL, Allende Markixana I, Alfaro Rubio A, Ciudad Blanco C, Vázquez-Veiga H, Barchino Ortiz L, Descalzo MA, García-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. — View Citation

Delgado Jiménez Y, Camarero-Mulas C, Sanmartín-Jiménez O, Garcés JR, Rodríguez-Prieto MÃ, Alonso-Alonso T, Miñano Medrano R, López-Estebaranz JL, de Eusebio Murillo E, Redondo P, Ciudad-Blanco C, Toll 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 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. — View Citation

Ruiz-Salas V, Garcés JR, Alonso-Alonso T, Rodríguez-Prieto MA, Toll-Abelló A, Eusebio Murillo E, Miñano R, López-Estebaranz JL, Sanmartín-Jiménez O, Guillén Barona C, Allende Markixana I, Alfaro Rubio A, Delgado Jiménez Y, Navarro R, Barchino Ortiz L, Lázaro Ochaita P, Vilarasa E, Ciudad Blanco C, Vázquez-Veiga H, Artola Igarza JL, Alonso ML, García-Doval I, Descalzo MA, Redondo Bellón P. Description of patients excluded for Mohs surgery after pre-surgical evaluation: data from the Regesmohs Spanish registry. Actas Dermosifiliogr. 2018 May;109(4):346-350. doi: 10.1016/j.ad.2017.11.008. Epub 2018 Jan 17. English, Spanish. — View Citation

Ruiz-Salas V, Garcés JR, Miñano Medrano R, Alonso-Alonso T, Rodríguez-Prieto MÁ, López-Estebaranz JL, Sanmartín-Jiménez O, Guillén Barona C, Delgado Jiménez Y, Toll-Abelló A, Vargas Diez E, Ciudad Blanco C, Alfaro Rubio A, Allende Markixana I, de Eusebio Murillo E, Manubens-Mercadé E, Vázquez-Veiga H, Barchino Ortiz L, García-Doval I, Redondo Bellón 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. — View Citation

Outcome
Type	Measure	Description	Time frame
Primary	Tumor recurrence		6 years
Secondary	Short term outcomes	Bleeding, infection, abnormal scar, necrosis	1 month
Secondary	Use of resources	Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.	During surgery
Secondary	Impairments of body function and structure	presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other	6 years

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT03979872` - Risk Information and Skin-cancer Education for Undergraduate Prevention	N/A
Recruiting	`NCT04986748` - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Recruiting	`NCT05707286` - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting	`NCT05470283` - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	Phase 1
Recruiting	`NCT05077137` - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy	Phase 1
Active, not recruiting	`NCT02721459` - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma	Phase 1
Active, not recruiting	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting	`NCT05839912` - Excision of Lymph Node Trial (EXCILYNT) (Mel69)	N/A
Recruiting	`NCT04971499` - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma	Phase 1/Phase 2
Recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT05263453` - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation	Phase 2
Terminated	`NCT03399448` - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)	Phase 1
Completed	`NCT03348891` - TNF in Melanoma Patients Treated With Immunotherapy	N/A
Completed	`NCT03171064` - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment	Phase 2
Not yet recruiting	`NCT05539118` - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma	Phase 1/Phase 2
Recruiting	`NCT05171374` - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn	`NCT02854488` - Yervoy Pregnancy Surveillance Study
Completed	`NCT00297895` - Multicenter Selective Lymphadenectomy Trial II (MSLT-II)	N/A

External Links

Updated descrition of the study (in Spanish)

Spanish Registry of Mohs Surgery

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Country where clinical trial is conducted

References & Publications (6)

Outcome

External Links