Basal Cell CarcinomaNCT04795297
Observational Study of Correlation Between Recurrent Basal Cell Carcinoma and Localisation
An observational study of Basal Cell Carcinoma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
.During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form). Read more about this study
- Who is it for?
- Ages 16 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 804 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 20 Feb 2021
- 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 16 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cohort : All the resected BCC during one year in Montpellier University Hospital and Millau Hospital (both analyzed in anatomopathology unit in Montpellier University Hospital). Cases : All the cases of recurrent BCC, found after research in medical records or histopathology request form.
Who may be able to join
- Patients with resected BCC
- -Recurrent BCC with complete first resection
Who cannot join
- Biopsies of BCC,
- revised surgery of incomplete resection.
- Cases :
- Recurrent BCC with incomplete first resection, Patients with Gorlin syndrome (a genetic disease that increase risk of BCC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Basal Cell Carcinoma Operated at Montpellier University Hospital and Millau Hospital From February 2020 to February 2021 - Study of Correlation Between Localisation and Recurrence, and Other Criterias
.During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form).
From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with recurrent BCC were contacted to obtain agreement and more informations about the first resection and some clinical informations like sun exposure and phototype.
The statistical analysis focused on the localisation of recurrent BCC (with a complete first resection) compared to localisations of primary BCC in this population. The goal was to identified localisations with an increased risk of recurrences.
- Conditions
- Basal Cell Carcinoma
- Keywords
- Resection of BCC (Basal Cell Carcinoma), Recurrence of BCC (Basal Cell Carcinoma), Localisation
- 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 |
|---|---|---|
| recurrent BCC | recurrent BCC | |
| resected BCC | resected BCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC
Measured: 1 day
Secondary outcomes (3)
Analysis of correlation between localisation and histology characteristics
Analysis of correlation between localisation and histology characteristics
Measured: 1 day
Analysis of correlation between histological type and recurrence risk
Analysis of correlation between histological type and recurrence risk
Measured: 1 day
Analysis if there is a difference between first resection histological type and the recurrent histological type
Analysis if there is a difference between first resection histological type and the recurrent histological type
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Feb 2020
- Primary completion1 Feb 2021
- Study completion20 Feb 2021
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, MontpellierThe 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
- Retrospective
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Pons, Resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795297
- Sponsor's protocol ID
- RECHMPL21_0156
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Basal Cell Carcinoma Operated at Montpellier University Hospital and Millau Hospital From February 2020 to February 2021 - Study of Correlation Between Localisation and Recurrence, and Other Criterias
- ClinicalTrials.gov ID
- NCT04795297
- Acronym / sponsor ID
- RECHMPL21_0156
- Conditions
- Basal Cell Carcinoma
- Keywords
- Resection of BCC (Basal Cell Carcinoma), Recurrence of BCC (Basal Cell Carcinoma), Localisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 12 Mar 2021 (actual)
- 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.
.During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form).
From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with recurrent BCC were contacted to obtain agreement and more informations about the first resection and some clinical informations like sun exposure and phototype.
The statistical analysis focused on the localisation of recurrent BCC (with a complete first resection) compared to localisations of primary BCC in this population. The goal was to identified localisations with an increased risk of recurrences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recurrent BCC | – | –recurrent BCC |
| resected BCC | – | –resected BCC |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort : All the resected BCC during one year in Montpellier University Hospital and Millau Hospital (both analyzed in anatomopathology unit in Montpellier University Hospital). Cases : All the cases of recurrent BCC, found after research in medical records or histopathology request form.
Key inclusion criteria (2 listed)
- Patients with resected BCC
- -Recurrent BCC with complete first resection
Key exclusion criteria (4 listed)
- Biopsies of BCC,
- revised surgery of incomplete resection.
- Recurrent BCC with incomplete first resection, Patients with Gorlin syndrome (a genetic disease that increase risk of BCC)
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
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC
Time frame: 1 day
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC
3 secondary outcomes
Analysis of correlation between localisation and histology characteristics
Time frame: 1 day
Analysis of correlation between histological type and recurrence risk
Time frame: 1 day
Analysis if there is a difference between first resection histological type and the recurrent histological type
Time frame: 1 day
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 12 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Sophie Pons, Resident principal investigator
University Hospital, Montpellier
1 site 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, Montpellier at 1 site 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 2 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC (time frame: 1 day). 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 12 Mar 2021.