Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-02-25 @ 3:07 AM
Study NCT ID:
NCT00682812
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2008-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Significance of the High-risk Hpv Viral Load
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2008-05-20', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the meaning of a viral load raised in HPV oncogenic', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt', 'timeFrame': '36 months'}, {'measure': 'Estimate the correlation between the viral load of the HPV oncogenic and the level of transcription of the genes coding for oncoproteines E6 and E7', 'timeFrame': '36 months'}, {'measure': 'Estimate the correlation between the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells', 'timeFrame': '36 months'}, {'measure': 'Estimate the correlation between a viral load raised in HPV oncogenic and a presence of HPV in the circulating blood of the infected patients', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HPV Infections']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.', 'detailedDescription': "We will particularly evaluate if the HR-HPV viral load:\n\n* Is correlated to the transcription of the genes of the oncoproteins E6 and E7\n* Is predictive of the integration of the virus in infected cells\n* Is predictive of the presence of HPV in patients' blood\n* Influences the local and systemic immunologic response"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The women consulting for the therapeutic care (by hysterectomy or conization) of a LIEHG or a cervical cancer (carcinoma epidermoid or adenocarcinoma) confirmed by the anatomopathologique analysis of a preoperative cervical biopsy.\n* The women having a normal cervix consulting for the surgical care by hysterectomy of a good-hearted pathology of the womb. The normality of the cervix will be confirmed by the anatomopathologique analysis of the detail of hysterectomy\n* The patients participating in this study will have to be of more than 18 years old. All the subjects will be profitable of a regime of Social Security.\n\nExclusion Criteria:\n\n* The patients having a LIEBG\n* The patients incapable to receive the information enlightened on the progress and the objectives of the study\n* The patients not having signed enlightened assent'}, 'identificationModule': {'nctId': 'NCT00682812', 'briefTitle': 'Significance of the High-risk Hpv Viral Load', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Significance of the High-risk Hpv Viral Load', 'orgStudyIdInfo': {'id': '2007-A01335-48'}, 'secondaryIdInfos': [{'id': '2007-30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '125 womens with normal cervix', 'interventionNames': ['Other: 2 cervical takings and 2 sampling of blood']}, {'type': 'OTHER', 'label': '2', 'description': '105 womens with an intraepithelial lesion', 'interventionNames': ['Other: 2 cervical takings and 2 sampling of blood']}, {'type': 'OTHER', 'label': '3', 'description': '105 womens with a cancer of the cervix', 'interventionNames': ['Other: 2 cervical takings and 2 sampling of blood']}], 'interventions': [{'name': '2 cervical takings and 2 sampling of blood', 'type': 'OTHER', 'description': '* 2 cervical takings\n* 2 sampling of blood before and after the total hysterectomy', 'armGroupLabels': ['1']}, {'name': '2 cervical takings and 2 sampling of blood', 'type': 'OTHER', 'description': '* cervical taking during the cervical conization\n* 2 sampling of blood before and after the intervention', 'armGroupLabels': ['2']}, {'name': '2 cervical takings and 2 sampling of blood', 'type': 'OTHER', 'description': '* cervical taking during the pelvien examination under general anesthetic realized systematically during the balance sheet of pre-therapeutic evaluation\n* 2 sampling of blood before and after the intervention', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord, service de gynécologie-obstétrique', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Xavier CARCOPINO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique des Hopitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}