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Completed

NCT Number: NCT02825511

Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

Assessment of the concordance of the initial clinical and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wiart (Dermatologue - Armentieres), Armentières, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Société de Dermatologie Française

Registry information

Official study title

Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years

Acronym: CAC-CBC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2016
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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