Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-17 @ 5:28 PM
Study NCT ID:
NCT06522256
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Transversal, non-comparative, multicenter study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)', 'timeFrame': 'Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.'}], 'secondaryOutcomes': [{'measure': 'HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome', 'timeFrame': 'at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.'}, {'measure': 'Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.', 'timeFrame': '10 years after participation in the ANRS IPERGAY trial', 'description': 'Lesions and condylomas are described as follows: location and type.'}, {'measure': 'Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.', 'timeFrame': 'at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.'}, {'measure': 'Nature of abnormalities on anal histology of lesions: location, type, grade', 'timeFrame': '10 years after participation in the ANRS IPERGAY trial'}, {'measure': 'Presence of different HPV virus types in the oropharynx', 'timeFrame': 'at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSIL'], 'conditions': ['HPV Infection', 'Anal Cancer']}, 'descriptionModule': {'briefSummary': 'HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.', 'detailedDescription': 'The study aims to enrol 80 to 100 participants in French clinical centres. All the participants have participated to the IPERGAY HPV substudy.\n\nThe study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.\n\nAlso, the study proposes to:\n\n* study the association between the presence of HSIL and/or anal cancer and HPV molecular signatures during participation in the ANRS IPERGAY trial and 10 years after.\n* study the evolution of HPV molecular signatures from participation in the ANRS IPERGAY to current study\n* compare HRA results with anal cytology results\n* compare the results of anal cytology concomitant with HRA with those obtained during participation in the ANRS IPERGAY trial.\n* study factors associated with the presence of HSIL and/or anal cancer.\n* compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;\n* Informed and written signed consent\n* Participant with regular health insurance\n\nExclusion Criteria:\n\n* Participant under guardianship or curatorship\n* Participant with free State medical assistance\n* Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.'}, 'identificationModule': {'nctId': 'NCT06522256', 'acronym': 'HPVsign', 'briefTitle': 'Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial', 'orgStudyIdInfo': {'id': 'ANRS0251s-HPVSign'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High-resolution anoscopy', 'interventionNames': ['Procedure: High-resolution anoscopy']}], 'interventions': [{'name': 'High-resolution anoscopy', 'type': 'PROCEDURE', 'description': 'The study includes 2 visits:\n\n* a medical consultation for inclusion\n* a proctology consultation including the performance of an AHR associated or not with biopsy sampling', 'armGroupLabels': ['High-resolution anoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stanislas Ogoudjobi', 'role': 'CONTACT', 'email': 'stanislas.ogoudjobi@chu-lyon.fr'}, {'name': 'Dulce Alfaiate, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Croix Rousse - SMIT', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bénédicte Loze', 'role': 'CONTACT', 'email': 'benedicte.loze@aphp.fr'}, {'name': 'Caroline Lascoux-Combe, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint-Louis - SMIT', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibaut Pélagie', 'role': 'CONTACT', 'email': 'pelagie.thibaut@aphp.fr'}, {'name': 'Gilles Pialoux, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Tenon - SMIT', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Fatoumata Coulibaly', 'role': 'CONTACT', 'email': 'fatoumata.coulibay@inserm.fr', 'phone': '0144236110', 'phoneExt': '+33'}, {'name': 'Mathilde Ghislain, MSc', 'role': 'CONTACT', 'email': 'mathilde.ghislain@inserm.fr', 'phone': '0145595229', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Caroline Lascoux-Combe, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'David Veyer, Pharm D,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Européen Georges-Pompidou'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'INSERM SC10-US19', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}