Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-04-09 @ 11:41 PM
Study NCT ID:
NCT01877135
Status:
UNKNOWN
Last Update Posted:
2015-03-05
First Post:
2013-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A liquid phase anal smear'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2013-06-11', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'at least one anal cancer', 'timeFrame': '3-year incidence of anal carcinoma', 'description': 'the first diagnosis of anal carcinoma'}], 'secondaryOutcomes': [{'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", 'timeFrame': '3 years', 'description': "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)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anal carcinoma', 'AIN3', 'cohort study'], 'conditions': ['Anal AIN3', 'Anal Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '"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.\n\nObjective : Evaluation of the AC incidence in patient with anal AIN3 lesions, and factors associated with this AC.\n\nPopulation : 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.\n\nStudy 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.\n\nOutcome : 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.\n\nStatistics : The incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.\n\nNumber 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"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients consulting a proctologist in primary care or in hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be included in the cohort, patients have to:\n\n\\- have an anal AIN3 (including Bowen's disease) diagnosed by histology (screening population, post-operative discovery…)\n\n* 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.\n* 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.\n\nTaking 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.\n\n\\- Patient's non opposition to study\n\nExclusion Criteria:\n\n* history of anal carcinoma without any history of anal AIN3 lesion\n* impossible follow-up for the duration of the study (3 years or more)\n* patient aged under 18"}, 'identificationModule': {'nctId': 'NCT01877135', 'acronym': 'AIN3', 'briefTitle': 'Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients', 'organization': {'class': 'OTHER', 'fullName': 'French Society of Coloproctology'}, 'officialTitle': 'Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients', 'orgStudyIdInfo': {'id': '11-LAZ-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anal AIN3', 'description': 'patients \\> 18 years, with anal AIN3, without history of anal carcinoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'state': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Abramowitz, MD', 'role': 'CONTACT', 'email': 'laurent.abramowitz@bch.aphp.fr', 'phone': '0033 1 40 25 72 02'}, {'name': 'Charlotte Bord, MD', 'role': 'CONTACT', 'email': 'charlotte.bord@free.fr', 'phone': '0033 6 44 07 07 94'}, {'name': 'Laurent Abramowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Laurent Abramowitz, MD', 'role': 'CONTACT', 'email': 'laurent.abramowitz@bch.aphp.fr', 'phone': '00331 40 25 87 16'}, {'name': 'Charlotte Bord, MD', 'role': 'CONTACT', 'email': 'charlotte.bord@free.fr', 'phone': '00334 67 67 91 78'}], 'overallOfficials': [{'name': 'Laurent Abramowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Society of Coloproctology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société Nationale Française de Gastroentérologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}