Basal Cell CarcinomaCAC-CBCNCT02825511
Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by University Hospital, Bordeaux at 17 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 2,738 participants
- Where
- 17 sitesFrance
- Study dates
- 16 Mar 2015to 6 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: BCC primitive, clinically suspected or previously biopsied
Who may be able to join
- 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
Who cannot join
- Recurrent CBC
- prior medical treatment
- BCC assigned to another operator for removal
- Genodermatosis underlying (xeroderma pigmentosum - Gorlin syndrome)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Wiart (Dermatologue - Armentieres)
Armentières, 59280
Dupin (Dermatologue - Auch)
Auch, 32000
University Hospital of Bordeaux - Hospital Saint André
Bordeaux, 33000
Will (Dermatologue - Brumath)
Brumath, 67170
Ruto (Dermatologue - Evreux)
Évreux, 27000
Jacquet (Dermatologue - Hyeres)
Hyères, 83400
Tranchand (Dermatologue - Le Puy En Velay)
Le Puy-en-Velay, 43000
Groupe Hospitalier de L'Institut Catholique de Lille
Lille, 51000
Bacconier (Dermatologue - Marseille)
Marseille, 130005
Haberstroh (Dermatologue - Mulhouse)
Mulhouse, 68100
Bolzinger (Dermatologue - Nay)
Nay, 64800
CHU de Nice
Nice, 06000
Chaussade (Dermatologue - Paris)
Paris, 75000
Tanguy (Dermatologue - Pau)
Pau, 64000
Bailly (Dermatologue - Toulouse)
Toulouse, 31000
Chu de Toulouse
Toulouse, 31000
Lulin (Dermatologue - Vendome)
Vendôme, 41100
About this study
Official title: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years
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.
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, histological diagnosis, prognostic impact
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimension of basal cell carcinoma.
Measured: Day 1
Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform)
Measured: Day 1
Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform)
Measured: Day 1
Secondary outcomes (2)
Number of the disease according to region (head, leg, arm, eyelid, lip,...)
Measured: Day 1
Clinical aggressiveness Score with "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES) criteria
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start16 Mar 2015
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,738 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Société de Dermatologie Française
- Responsible party
- Sponsor
- Investigators
- Jean Michel AMICI, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825511
- Sponsor's protocol ID
- CHUBX 2014/18
- Acronym
- CAC-CBC
- Status last verified
- Oct 2020
- First submitted
- 4 Jul 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years
- ClinicalTrials.gov ID
- NCT02825511
- Acronym / sponsor ID
- CAC-CBC / CHUBX 2014/18
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, histological diagnosis, prognostic impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,738 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Société de Dermatologie Française
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the concordance of the initial clinical and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BCC primitive, clinically suspected or previously biopsied
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Recurrent CBC
- prior medical treatment
- BCC assigned to another operator for removal
- Genodermatosis underlying (xeroderma pigmentosum - Gorlin syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dimension of basal cell carcinoma.
Time frame: Day 1
Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform)
Time frame: Day 1
Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform)
Time frame: Day 1
2 secondary outcomes
Number of the disease according to region (head, leg, arm, eyelid, lip,...)
Time frame: Day 1
Clinical aggressiveness Score with "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES) criteria
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Michel AMICI, MD principal investigator
University Hospital, Bordeaux
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by University Hospital, Bordeaux at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimension of basal cell carcinoma. (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.