Anal AIN3AIN3NCT01877135
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
An observational study of Anal AIN3 and Anal Carcinoma, run by French Society of Coloproctology at 1 site in France.
Trial summary
Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal AIN3, Anal Carcinoma
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Jun 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: patients consulting a proctologist in primary care or in hospital
Who may be able to join
- To be included in the cohort, patients have to:
- have an anal AIN3 (including Bowen's disease) diagnosed by histology (screening population, post-operative discovery…)
- Aposteriori for patients with a history of anal AIN3 complicated or not by an anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since January 1st 2000.
- At the diagnostic for the new anal AIN3 Units care involved in the study are those involved in the follow-up of patients with anal pathologies en France, especially anal cancer. Samples are analyzed by the laboratories of anatomopathology of the hospitals where the patients are diagnosed. These points make the histological data bases reliable and allow clearly identifying cases of anal ain3 retrospectively since 2000.
- Taking in account the number and quality of the units care involved in the study and the way cases are identified, we think our recruitment will be exhaustive in France, to limit selection bias.
- Patient's non opposition to study
Who cannot join
- history of anal carcinoma without any history of anal AIN3 lesion
- impossible follow-up for the duration of the study (3 years or more)
- patient aged under 18
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard
Paris, Paris, 75018
Laurent Abramowitz, MD, 0033 1 40 25 72 02, laurent.abramowitz@bch.aphp.fr
Charlotte Bord, MD, 0033 6 44 07 07 94, charlotte.bord@free.fr
About this study
Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.
Read the detailed description
"Background : Incidence of anal carcinoma (AC) is considerably increasing, but no data on risk of AC in patient with anal AIN3 lesions are available, nor french recommendations about screening and treatment of anal AIN3 lesions.
Objective : Evaluation of the AC incidence in patient with anal AIN3 lesions, and factors associated with this AC.
Population : Patients with a diagnosis of anal AIN3 lesion will be included and followed for 3 years. Patients with past history of AC won't be included.
Study design : Retrospective cohort study will be conducted from 2000 using diagnostic codes of anal AIN3 lesion in histo-pathology departments. Then a prospective cohort study will be conducted with new diagnoses of anal AIN3 lesion.
Outcome : The main outcome is histology proven AC. AC identification can be done either by using diagnostic codes of AC in histo-pathology departments (for retrospective cases), or prospectively.
Statistics : The incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.
Number of patients : 1000 Number of centers : 35 Length of follow-up: 3 years at least Length of study : 3 years of inclusion and 3 years of follow-up at least"
- Conditions
- Anal AIN3, Anal Carcinoma
- Keywords
- anal carcinoma, AIN3, cohort study
- Medical subject headings
- Anus Neoplasms
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 |
|---|---|---|
| Anal AIN3 | patients > 18 years, with anal AIN3, without history of anal carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
at least one anal cancer
the first diagnosis of anal carcinoma
Measured: 3-year incidence of anal carcinoma
Secondary outcomes (2)
Observance
Observance defined by at least one consult a year, in case of history anal dysplasia, or 2 consults a year, in case of persistence of anal dysplasia
Measured: 3 years
patient's feelings about his therapeutic care and impact on his emotional life
Patient's feelings about his therapeutic care and impact on his emotional life will be evaluated with a single question with an analogical visual scale from 0 (I'm feeling very bad) to 10 (I'm feeling very good)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal AIN3Studies 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
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Society of Coloproctology
- Sponsor type
- University, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Responsible party
- Sponsor
- Investigators
- Laurent Abramowitz, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877135
- Sponsor's protocol ID
- 11-LAZ-001
- Acronym
- AIN3
- Status last verified
- Sep 2013
- First submitted
- 11 Jun 2013
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
- ClinicalTrials.gov ID
- NCT01877135
- Acronym / sponsor ID
- AIN3 / 11-LAZ-001
- Conditions
- Anal AIN3, Anal Carcinoma
- Keywords
- anal carcinoma, AIN3, cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- French Society of ColoproctologyUniversity, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Study start
- Aug 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 13 Jun 2013 (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.
Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.
Detailed description
"Background : Incidence of anal carcinoma (AC) is considerably increasing, but no data on risk of AC in patient with anal AIN3 lesions are available, nor french recommendations about screening and treatment of anal AIN3 lesions.
Objective : Evaluation of the AC incidence in patient with anal AIN3 lesions, and factors associated with this AC.
Population : Patients with a diagnosis of anal AIN3 lesion will be included and followed for 3 years. Patients with past history of AC won't be included.
Study design : Retrospective cohort study will be conducted from 2000 using diagnostic codes of anal AIN3 lesion in histo-pathology departments. Then a prospective cohort study will be conducted with new diagnoses of anal AIN3 lesion.
Outcome : The main outcome is histology proven AC. AC identification can be done either by using diagnostic codes of AC in histo-pathology departments (for retrospective cases), or prospectively.
Statistics : The incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.
Number of patients : 1000 Number of centers : 35 Length of follow-up: 3 years at least Length of study : 3 years of inclusion and 3 years of follow-up at least"
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal AIN3 | – | –patients > 18 years, with anal AIN3, without history of anal carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients consulting a proctologist in primary care or in hospital
Key inclusion criteria (6 listed)
- have an anal AIN3 (including Bowen's disease) diagnosed by histology (screening population, post-operative discovery…)
- Aposteriori for patients with a history of anal AIN3 complicated or not by an anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since January 1st 2000.
- At the diagnostic for the new anal AIN3 Units care involved in the study are those involved in the follow-up of patients with anal pathologies en France, especially anal cancer. Samples are analyzed by the laboratories of anatomopathology of the hospitals where the patients are diagnosed. These points make the histological data bases reliable and allow clearly identifying cases of anal ain3 retrospectively since 2000.
- Taking in account the number and quality of the units care involved in the study and the way cases are identified, we think our recruitment will be exhaustive in France, to limit selection bias.
- Patient's non opposition to study
Key exclusion criteria (3 listed)
- history of anal carcinoma without any history of anal AIN3 lesion
- impossible follow-up for the duration of the study (3 years or more)
- patient aged under 18
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
at least one anal cancer
Time frame: 3-year incidence of anal carcinoma
the first diagnosis of anal carcinoma
2 secondary outcomes
Observance
Time frame: 3 years
patient's feelings about his therapeutic care and impact on his emotional life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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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.
Laurent Abramowitz, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Anal AIN3 and Anal Carcinoma, run by French Society of Coloproctology 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 6 inclusion and 3 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 5 Mar 2015. 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 Laurent Abramowitz, MD (00331 40 25 87 16, laurent.abramowitz@bch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
at least one anal cancer (time frame: 3-year incidence of anal carcinoma). 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 5 Mar 2015.