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Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma (CAC-CBC)

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ClinicalTrials.gov Identifier: NCT02825511
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief Summary:
Assessment of the concordance of the initial clinical and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.

Condition or disease
Basal Cell Carcinoma

Detailed Description:

The skin cancer is a major public health problem whose incidence is increasing due to the aging population. Among them, basal cell carcinoma (BCC) is a daily concern the dermatologist. The recommendation of good practice for the BCC of support has been established according to French agency methodology in 2004 : "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES). This classification is based on clinical and pathological use of sometimes mismatched terminology pretending to clinical reality with discrepancies between the clinical appearance and histology. On the other hand the simplified classification of recommendations has never been tested and validated on a large series of BCC. Probabilistic margins applied based on clinical assessment of clinical and pathological subtype, it seems interesting to evaluate the consistency of the initial clinical diagnosis and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.

This study could lead to improved clinical and pathological classification and allow amending the current recommendations of the surgical management of the BCC.

Study Design
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Study Type : Observational
Actual Enrollment : 2738 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years
Actual Study Start Date : March 16, 2015
Actual Primary Completion Date : September 6, 2019
Actual Study Completion Date : September 6, 2019
Groups and Cohorts
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Group/Cohort
A cohort of basal cell carcinoma
A cohort of surgically treated BCC, primitive clinically suspected or previously biopsied on a 4-month period, an expected number of 3 200 cases. The management of the BCC will be consistent with current recommendations. BCC recurrence and those who received prior medical treatment will be excluded.


Outcome Measures
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Primary Outcome Measures :
  1. Dimension of basal cell carcinoma. [ Time Frame: Day 1 ]
  2. Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform) [ Time Frame: Day 1 ]
  3. Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform) [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Number of the disease according to region (head, leg, arm, eyelid, lip,...) [ Time Frame: Day 1 ]
  2. Clinical aggressiveness Score with "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES) criteria [ Time Frame: Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
BCC primitive, clinically suspected or previously biopsied
Criteria

Inclusion Criteria:

  • Primitive BCC
  • BCC clinically suspected or previously biopsied
  • Supports conventional surgical or micrographic techniques.
  • Patient able to sign a consent after reading the briefing note

Exclusion Criteria:

  • Recurrent CBC
  • prior medical treatment
  • BCC assigned to another operator for removal
  • Genodermatosis underlying (xeroderma pigmentosum - Gorlin syndrome)
Contacts and Locations
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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): NCT02825511


Locations
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Sponsors and Collaborators
University Hospital, Bordeaux
Société de Dermatologie Française
Investigators
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Principal Investigator: Jean Michel AMICI, MD University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02825511    
Other Study ID Numbers: CHUBX 2014/18
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Bordeaux:
basal cell carcinoma, histological diagnosis, prognostic impact
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell