Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06158802
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2023-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunization coverage rate for human papillomavirus vaccine', 'timeFrame': 'Day 1', 'description': 'Percentage of patients with or without a chronic illness who have received HPV vaccination (complete vaccination schedule).'}], 'secondaryOutcomes': [{'measure': 'Intention of vaccination by human papillomavirus vaccine by the usual health professionals', 'timeFrame': 'Day 1', 'description': 'Percentage of patients with or without a chronic illness who have been offered HPV vaccination.'}, {'measure': 'Category of health professionals offering vaccination by human papillomavirus vaccine', 'timeFrame': 'Day 1', 'description': 'Patients with or without a chronic illness to whom vaccination has been offered/prescribed :\n\n* Percentage of vaccination offered/prescribed by the general practitioner\n* Vaccination percentage proposed/prescribed by the pediatrician,\n* Vaccination percentage proposed/prescribed by the gynecologist,\n* Percentage of vaccination proposed/prescribed by the specialist doctor,\n* Percentage of vaccination offered/prescribed by another healthcare professional.'}, {'measure': 'Reasons for non-vaccination by human papillomavirus vaccine', 'timeFrame': 'Day 1', 'description': 'Patients suffering from a chronic illness or not and not vaccinated:\n\n* Percentage of patients not vaccinated due to fear/apprehension,\n* Percentage of patients not vaccinated because they did not know this vaccine,\n* Percentage of patients not vaccinated because they are against vaccination,\n* Percentage of patients not vaccinated due to lack of time.'}, {'measure': 'Description of parameters that may impact vaccination coverage for human papillomavirus vaccine', 'timeFrame': 'Day 1', 'description': "Description of patients with or without a chronic illness and vaccinated or not against HPV\n\n* Average age of patients at the time of inclusion,\n* Socio-professional category of parents (father's and mother's profession),\n* Average age at menarche,\n* Assessment of risk behaviors (percentage of patients who smoke, percentage of patients who consume alcohol),\n* Percentage of patients who have started their sexual life,\n* Average age at first sexual intercourse,\n* Percentage of patients followed by a pediatrician,\n* Percentage of patients followed by a general practitioner,\n* Percentage of patients followed by a gynecologist."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human papillomavirus vaccine', 'Young women with chronic condition', 'Vaccination coverage rate'], 'conditions': ['Human Papillomavirus Vaccine', 'Chronic Condition']}, 'referencesModule': {'references': [{'pmid': '28928039', 'type': 'BACKGROUND', 'citation': 'Hofstetter AM, Camargo S, Natarajan K, Rosenthal SL, Stockwell MS. Vaccination Coverage of Adolescents With Chronic Medical Conditions. Am J Prev Med. 2017 Nov;53(5):680-688. doi: 10.1016/j.amepre.2017.07.017. Epub 2017 Sep 18.'}, {'pmid': '28760611', 'type': 'BACKGROUND', 'citation': 'Gras-Le Guen C, Legrand A, Caquard M, Micaelli X, Picherot G, Lacroix S, Volteau C, Launay E. Chronically ill adolescents are also incompletely vaccinated: A cross-sectional study in France. Vaccine. 2017 Aug 24;35(36):4707-4712. doi: 10.1016/j.vaccine.2017.07.042. Epub 2017 Jul 29.'}, {'pmid': '22831900', 'type': 'BACKGROUND', 'citation': 'Hoffman L, Okcu MF, Dreyer ZE, Suzawa H, Bryant R, Middleman AB. Human papillomavirus vaccination in female pediatric cancer survivors. J Pediatr Adolesc Gynecol. 2012 Oct;25(5):305-7. doi: 10.1016/j.jpag.2012.05.004. Epub 2012 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic disease and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.', 'detailedDescription': 'Girls and young women with chronic condition are at higher risk for infections that can be prevented by vaccination. Human papillomavirus infection is very common, one of the three most common in the general population. A vaccine exists to significantly prevent this infection and its complications.\n\nIn France, it is advisable to vaccinate girls and boys from the age of 9 years and as soon as possible in the case of acquired immunodeficiency since these patients are more likely to be suffering from cancer induced by the human papillomavirus.\n\nIn France, the overall rate of vaccination coverage for girls is 21%, which is significantly lower than in several other industrialized countries.\n\nThe vaccination coverage rate for human papillomavirus in patients with chronic diseases may be even lower.\n\nThe main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic condition and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '11 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged from 11 to 20 to cover the recommended age window for HPV vaccination, ie between 11 and 14 years old, with the possibility of catching up between 15 and 19 years of age (Public Health France, 2019).\n\n"Chronic condition" group: type 1 diabetes, metabolic diseases, immuno-hematological diseases, cystic fibrosis, sickle cell disease, kidney transplant, heart disease and inflammatory bowel disease, rare anorectal and pelvic malformations. Recruitment at the Necker-Enfants Malades Hospital and at the Specialized Medical Center for Children and Adolescents in Paris.\n\n"Control" group: patients in good health. Recruitment at the Specialized Medical Center for Children and Adolescents in Paris.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Information and non-opposition of major patients and holders of parental authority of minor patients and minor patients\n* Girls and young women aged 11 to 20\n* To be followed at the Necker-Enfants Malades Hospital ("chronic condition" group)\n* To be followed at the Specialized Medical Center for Children and Adolescents ("control" group)\n* Have a chronic condition ("chronic condition" group) :\n\n * Diabetes type 1\n * Metabolic diseases\n * Patients followed in immuno-hematology\n * Cystic Fibrosis\n * Sickle\n * Kidney transplant\n * Heart Disease\n * Inflammatory bowel diseases\n * Rare anorectal and pelvic anomalies\n* Live in France\n* Comprehension of the French language (oral and written)\n\nExclusion Criteria:\n\n* Have a contraindication to the HPV vaccine - Gardasil 9 (Vidal Hoptimal, 2018)\n* Have a contraindication to the HPV vaccine - Gardasil (Vidal Hopitmal, 2018)\n* Have a contraindication to HPV vaccine - Cervarix (Vidal Hoptimal, 2018)'}, 'identificationModule': {'nctId': 'NCT06158802', 'acronym': 'MC-HPV', 'briefTitle': 'Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease', 'orgStudyIdInfo': {'id': 'APHP210417'}, 'secondaryIdInfos': [{'id': '2021-A02421-40', 'type': 'OTHER', 'domain': 'IDRCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic condition', 'description': 'Girls and young women between the ages of 11 and 20 suffering from chronic condition', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Control', 'description': 'Girls and young women between the ages of 11 and 20 in good health', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire on human papillomavirus vaccine status of girls and young women and modalities of the vaccination or reason of the non-vaccination.\n\nThe questionnaire is completed by the patient.', 'armGroupLabels': ['Chronic condition', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75011', 'city': 'Paris', 'country': 'France', 'facility': "Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA)", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Sabrina DA COSTA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Alaa CHEIKHELARD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}