Clinical trial · Observational
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
NCT01877135CI-TRIAL-00016997AIN3unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal AIN3 | — | UNRESOLVED | — |
| Anal Carcinoma | Anal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Anal AIN3
- description
- patients \> 18 years, with anal AIN3, without history of anal carcinoma
Primary outcomes (1)
- measure
- at least one anal cancer
- timeFrame
- 3-year incidence of anal carcinoma
- description
- the first diagnosis of anal carcinoma
Secondary outcomes (2)
- measure
- Observance
- timeFrame
- 3 years
- description
- 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
- measure
- patient's feelings about his therapeutic care and impact on his emotional life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.