Carcinoma, Basal CellBACHIMONCT00699829
Mohs Versus Traditional Surgery - Basal-Cell Carcinomas (BCC)
An observational study of Carcinoma, Basal Cell, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial summary
Mohs' micrographic surgery (MMS) is a treatment of choice for high recurrence risk basal-cell carcinomas (BCC). Realized under local anaesthesia, it induces very low recurrence rates and spares unnecessary excision of intact surrounding tissues, thus decreasing the needs for flaps, skin grafts, and allows immediate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to not given
- 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: Patients de services de dermatologie et/ou chir plastique
Who may be able to join
- Age ≥ 18
- Histologically proved cutaneous BCC
- Categorized as "bad prognostic" according to the 2004 recommendations of ANAES
- morpheaform or ill-limited clinical forms and histologically aggressive forms (morpheaform, micronodular, infiltrating, squamous differentiation) OR
- already recurred BCC (except for superficial BCCs) OR
- nodular BCCs from the high-risk zone (nose and peri-orificial areas of the head) and with diameter larger than 1 cm.
- Life expectancy greater than 3 years according to the investigator's opinion.
- Patient being informed and having signed the consent to participate to the study
Who cannot join
- History of X-ray therapy in the territory of the BCC
- Counter-indication to surgery
- Life expectancy < 3 years
- superficial BCCs, even if recurred
- Patient being unable to attend future follow-up visits
- Patient with severe cognitive impairment
- Patient not affiliated to a social security regimen
Trial locations and contacts
1 site in 1 country.
Pr Philippe SAIAG contact
France1 site, 1 recruiting
- Recruiting
Hôpital Ambroise Paré
Boulogne, 92100
Philippe SAIAG, +33 1 49 09 56 73
About this study
Official title: Comparative Medico-Economic Evaluation of Micrographic Mohs Surgery (MMS) and Traditional Surgical Excision With Immediate or Differed Reconstruction to Treat High Recurrence Risk Basal-Cell Carcinomas (BCC)
Mohs' micrographic surgery (MMS) is a treatment of choice for high recurrence risk basal-cell carcinomas (BCC). Realized under local anaesthesia, it induces very low recurrence rates and spares unnecessary excision of intact surrounding tissues, thus decreasing the needs for flaps, skin grafts, and allows immediate reconstruction…. Its disadvantages are mainly: need for a significant training of the operator, the pathologist and the non-medical personnel; longer duration of the procedure, with higher a priori costs, and constraints for the patient related to the duration of the intervention. Traditional surgical excision with immediate or differed reconstruction is the technique of reference. Provided that re-excisions are performed as long as previous ones do not guarantee free margins, it gives good results. Its real costs are poorly known and can be enhanced by several considerations: multiplicity of the operational acts if the initial excision is insufficient, more complex reconstruction procedures, duration of post-operative dressings, ….
The investigators' objective is to know the costs of the surgical treatment of the high risk CBC, comparing the CMM with the surgical excision with immediate or differed reconstruction, along with its effectiveness defined by the absence of recurrence. by its impact on the quality of life of the patient. It is a prospective, multicentric, comparative, not randomized, open, cohort study, of the type "here and elsewhere". Patients with high-risk CBC, as defined by the French ANAES Guidelines (2004), will be included:
Read more
- clinically morpheaform aspect or ill-limited margins, aggressive histological forms;
- already recurred BCC (except for superficial BCCs));
- nodular BCC located in the high-risk zone (nose, peri-orificial areas of the head) and with diameter larger than 1 cm.
The effectiveness will be measured by the rate of recurrence at 5 years (as measured by the prolongation of the follow-up after the surgical procedure). The utility from the patient point of view will be evaluated by a specific dermatologic quality of life questionnaire (Skindex) and by a generic questionnaire (Euroqol 5D), supplemented by a questionnaire of satisfaction of the care (Attkisson). The economic perspectives studied will be those of the hospital, of the payer and of the society. Direct medical costs will be evaluated by micro-costing. The main production factors implied in the realization of one CMM or one traditional surgery in dermatology/surgery and anatomopathology wards will be identified, counted, and developed. The measuring units will be the estimate of the time devoted to each individual procedure, reported to the total activity of each ward and the wages of the various categories of personnel implied, and the unit costs in consumable and redeemable material, reported to their utilisation factor. The hospital indirect costs will be estimated by the financial services of the hospitals. Accrual of 150 CMM and 300 traditional excisions will be performed within a two year period of time.
- Conditions
- Carcinoma, Basal Cell
- 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 |
|---|---|---|
| 1 | Mohs' micrographic surgery (MMS) | |
| 2 | Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility ratio
Measured: 2 years
Secondary outcomes (1)
2 and 5 years survival
Measured: 2 & 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Investigators
- Philippe SAIAG, Principal investigator, Hospital Ambroise Paré ParisJean-Marie SERVANT, Principal investigator, Hôpital Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699829
- Sponsor's protocol ID
- P070158
- Acronym
- BACHIMO
- Status last verified
- Feb 2009
- First submitted
- 6 May 2008
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Medico-Economic Evaluation of Micrographic Mohs Surgery (MMS) and Traditional Surgical Excision With Immediate or Differed Reconstruction to Treat High Recurrence Risk Basal-Cell Carcinomas (BCC)
- ClinicalTrials.gov ID
- NCT00699829
- Acronym / sponsor ID
- BACHIMO / P070158
- Conditions
- Carcinoma, Basal Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Jun 2008
- First posted
- 18 Jun 2008 (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.
Mohs' micrographic surgery (MMS) is a treatment of choice for high recurrence risk basal-cell carcinomas (BCC). Realized under local anaesthesia, it induces very low recurrence rates and spares unnecessary excision of intact surrounding tissues, thus decreasing the needs for flaps, skin grafts, and allows immediate reconstruction…. Its disadvantages are mainly: need for a significant training of the operator, the pathologist and the non-medical personnel; longer duration of the procedure, with higher a priori costs, and constraints for the patient related to the duration of the intervention. Traditional surgical excision with immediate or differed reconstruction is the technique of reference. Provided that re-excisions are performed as long as previous ones do not guarantee free margins, it gives good results. Its real costs are poorly known and can be enhanced by several considerations: multiplicity of the operational acts if the initial excision is insufficient, more complex reconstruction procedures, duration of post-operative dressings, ….
The investigators' objective is to know the costs of the surgical treatment of the high risk CBC, comparing the CMM with the surgical excision with immediate or differed reconstruction, along with its effectiveness defined by the absence of recurrence. by its impact on the quality of life of the patient. It is a prospective, multicentric, comparative, not randomized, open, cohort study, of the type "here and elsewhere". Patients with high-risk CBC, as defined by the French ANAES Guidelines (2004), will be included:
- clinically morpheaform aspect or ill-limited margins, aggressive histological forms;
- already recurred BCC (except for superficial BCCs));
- nodular BCC located in the high-risk zone (nose, peri-orificial areas of the head) and with diameter larger than 1 cm.
The effectiveness will be measured by the rate of recurrence at 5 years (as measured by the prolongation of the follow-up after the surgical procedure). The utility from the patient point of view will be evaluated by a specific dermatologic quality of life questionnaire (Skindex) and by a generic questionnaire (Euroqol 5D), supplemented by a questionnaire of satisfaction of the care (Attkisson). The economic perspectives studied will be those of the hospital, of the payer and of the society. Direct medical costs will be evaluated by micro-costing. The main production factors implied in the realization of one CMM or one traditional surgery in dermatology/surgery and anatomopathology wards will be identified, counted, and developed. The measuring units will be the estimate of the time devoted to each individual procedure, reported to the total activity of each ward and the wages of the various categories of personnel implied, and the unit costs in consumable and redeemable material, reported to their utilisation factor. The hospital indirect costs will be estimated by the financial services of the hospitals. Accrual of 150 CMM and 300 traditional excisions will be performed within a two year period of time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mohs' micrographic surgery (MMS) |
| 2 | – | –Conventional surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients de services de dermatologie et/ou chir plastique
Key inclusion criteria (8 listed)
- Age ≥ 18
- Histologically proved cutaneous BCC
- Categorized as "bad prognostic" according to the 2004 recommendations of ANAES
- Life expectancy greater than 3 years according to the investigator's opinion.
- Patient being informed and having signed the consent to participate to the study
Key exclusion criteria (7 listed)
- History of X-ray therapy in the territory of the BCC
- Counter-indication to surgery
- Life expectancy < 3 years
- superficial BCCs, even if recurred
- Patient being unable to attend future follow-up visits
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
Cost-utility ratio
Time frame: 2 years
1 secondary outcome
2 and 5 years survival
Time frame: 2 & 5 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
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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.
Pr Philippe SAIAG contact
Philippe SAIAG principal investigator
Hospital Ambroise Paré Paris
Jean-Marie SERVANT principal investigator
Hôpital Saint Louis
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 Carcinoma, Basal Cell, run by Hospital Ambroise Paré Paris 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pr Philippe SAIAG, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility ratio (time frame: 2 years). 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 16 Feb 2009.