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CompletedNCT02825511CAC-CBCUpdated Oct 14, 2020

Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

An observational study in Basal Cell Carcinoma, sponsored by University Hospital, Bordeaux. Completed at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,738
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Basal Cell Carcinoma

Keywords

  • basal cell carcinoma, histological diagnosis, prognostic impact
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 2,738 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

BCC primitive, clinically suspected or previously biopsied

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

Exclusion Criteria:

  • Recurrent CBC
  • prior medical treatment
  • BCC assigned to another operator for removal
  • Genodermatosis underlying (xeroderma pigmentosum - Gorlin syndrome)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,738 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

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

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Study locations

17 sites
  • Wiart (Dermatologue - Armentieres)
    Armentieres, 59280, France
  • Dupin (Dermatologue - Auch)
    Auch, 32000, France
  • University Hospital of Bordeaux - Hospital Saint André
    Bordeaux, 33000, France
  • Will (Dermatologue - Brumath)
    Brumath, 67170, France
  • Ruto (Dermatologue - Evreux)
    Evreux, 27000, France
  • Jacquet (Dermatologue - Hyeres)
    Hyeres, 83400, France
  • Tranchand (Dermatologue - Le Puy En Velay)
    Le Puy En Velay, 43000, France
  • Groupe Hospitalier de L'Institut Catholique de Lille
    Lille, 51000, France
  • Bacconier (Dermatologue - Marseille)
    Marseille, 130005, France
  • Haberstroh (Dermatologue - Mulhouse)
    Mulhouse, 68100, France
  • Bolzinger (Dermatologue - Nay)
    NAY, 64800, France
  • CHU de Nice
    Nice, 06000, France
  • Chaussade (Dermatologue - Paris)
    Paris, 75000, France
  • Tanguy (Dermatologue - Pau)
    PAU, 64000, France
  • Bailly (Dermatologue - Toulouse)
    Toulouse, 31000, France
  • Chu de Toulouse
    Toulouse, 31000, France
  • Lulin (Dermatologue - Vendome)
    Vendome, 41100, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02825511
Lead sponsor
University Hospital, Bordeaux
Collaborators
Société de Dermatologie Française
Responsible party
Sponsor
First posted
Jul 7, 2016
Start date
Mar 16, 2015
Primary completion
Sep 6, 2019
Completion
Sep 6, 2019
Last update
Oct 14, 2020

Study contacts

Jean Michel AMICI, MD
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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