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Spanish Registry of Mohs Surgery (REGESMOHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310503
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología

Tracking Information
First Submitted Date December 1, 2014
First Posted Date December 8, 2014
Last Update Posted Date May 5, 2020
Study Start Date July 1, 2013
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2014)
Tumor recurrence [ Time Frame: 6 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2014)
  • Short term outcomes [ Time Frame: 1 month ]
    Bleeding, infection, abnormal scar, necrosis
  • Use of resources [ Time Frame: During surgery ]
    Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.
  • Impairments of body function and structure [ Time Frame: 6 years ]
    presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spanish Registry of Mohs Surgery
Official Title Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All consecutive patients considered for Mohs surgery in participating centers.
Condition
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Dermatofibrosarcoma
  • Melanoma
  • Histiocytoma, Malignant Fibrous
  • Neoplasms, Adnexal and Skin Appendage
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.
Study Groups/Cohorts Mohs surgery
Patients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants.
Intervention: Procedure: Mohs surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2014)
6000
Original Estimated Enrollment Same as current
Actual Study Completion Date February 29, 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All consecutive patients considered for Mohs surgery

Exclusion Criteria:

  • Under 18 years-old
  • Legally incompetent
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02310503
Other Study ID Numbers FAE-MOH-2013-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fundación Academia Española de Dermatología
Study Sponsor Fundación Academia Española de Dermatología
Collaborators Roche Pharma AG
Investigators
Study Director: Ignacio Garcia-Doval, MD, PhD Research Unit. Academia Española de Dermatologia y Venereologia (Spanish Academy of Dermatology)
PRS Account Fundación Academia Española de Dermatología
Verification Date May 2020