NCT02825511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,738

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2019

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

4.5 years

First QC Date

July 4, 2016

Last Update Submit

October 13, 2020

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinoma, histological diagnosis, prognostic impact

Outcome Measures

Primary Outcomes (3)

  • Dimension of basal cell carcinoma.

    Day 1

  • Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform)

    Day 1

  • Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform)

    Day 1

Secondary Outcomes (2)

  • Number of the disease according to region (head, leg, arm, eyelid, lip,...)

    Day 1

  • Clinical aggressiveness Score with "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES) criteria

    Day 1

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

BCC primitive, clinically suspected or previously biopsied

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Wiart (Dermatologue - Armentieres)

Armentières, 59280, France

Location

Dupin (Dermatologue - Auch)

Auch, 32000, France

Location

University Hospital of Bordeaux - Hospital Saint André

Bordeaux, 33000, France

Location

Will (Dermatologue - Brumath)

Brumath, 67170, France

Location

Ruto (Dermatologue - Evreux)

Évreux, 27000, France

Location

Jacquet (Dermatologue - Hyeres)

Hyères, 83400, France

Location

Tranchand (Dermatologue - Le Puy En Velay)

Le Puy-en-Velay, 43000, France

Location

Groupe Hospitalier de L'Institut Catholique de Lille

Lille, 51000, France

Location

Bacconier (Dermatologue - Marseille)

Marseille, 130005, France

Location

Haberstroh (Dermatologue - Mulhouse)

Mulhouse, 68100, France

Location

Bolzinger (Dermatologue - Nay)

Nay, 64800, France

Location

CHU de Nice

Nice, 06000, France

Location

Chaussade (Dermatologue - Paris)

Paris, 75000, France

Location

Tanguy (Dermatologue - Pau)

Pau, 64000, France

Location

Bailly (Dermatologue - Toulouse)

Toulouse, 31000, France

Location

Chu de Toulouse

Toulouse, 31000, France

Location

Lulin (Dermatologue - Vendome)

Vendôme, 41100, France

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Jean Michel AMICI, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

March 16, 2015

Primary Completion

September 6, 2019

Study Completion

September 6, 2019

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(17)