Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-30 @ 12:59 PM
Study NCT ID:
NCT06253169
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPV DNA Self-sampling in a General Practitioner's Office.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'HPV DNA smears from the cervix'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To compare the proportion of women who self-test for HPV DNA in a GP office versus those who refuse to take the test. To assess the overall proportion of women who self-test and the proportion in each study cohort.'}, {'measure': 'Evaluation of the frequency of positivity of the HPV tests taken.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Compare the proportion of women who will self-test positive for HPV DNA, including an assessment of positivity for HPV 16/18 and other HPV genotypes. To assess the overall proportion of women testing positive and the proportion in each study cohort.'}, {'measure': 'Evaluation of follow-up gynaecological care in women who tested positive.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To assess what proportion of women who self-test positive for HPV DNA will accept a gynecologic exam and to assess the results of the gynecologic visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevention', 'Cervical cancer', 'HPV test', 'Self-sampling'], 'conditions': ['Cervical Cancer', 'HPV Infection', 'Precancerous Lesion']}, 'referencesModule': {'references': [{'pmid': '37751376', 'type': 'BACKGROUND', 'citation': 'Slama J, Dvorak V, Trnkova M, Skrivanek A, Hrabcova K, Ovesna P, Novackova M. Is phased implementation of HPV testing and triage with dual staining the way to transform organized cytology screening? Eur J Cancer Prev. 2024 Mar 1;33(2):168-176. doi: 10.1097/CEJ.0000000000000844. Epub 2023 Sep 21.'}, {'pmid': '33562978', 'type': 'BACKGROUND', 'citation': 'Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243.'}, {'pmid': '38224266', 'type': 'BACKGROUND', 'citation': 'Ngo O, Chloupkova R, Cibula D, Slama J, Mandelova L, Hejduk K, Hajduch M, Minka P, Koudelakova V, Jaworek H, Trnkova M, Vanek P, Dvorak V, Dusek L, Majek O. Direct mailing of HPV self-sampling kits to women aged 50-65 non-participating in cervical screening in the Czech Republic. Eur J Public Health. 2024 Apr 3;34(2):361-367. doi: 10.1093/eurpub/ckad229.'}]}, 'descriptionModule': {'briefSummary': "One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in cervical screening.", 'detailedDescription': "Organized cervical screening in the Czech Republic has a long-term participation rate of about 56% of the target population. Despite active invitations through health insurance companies, a part of the population is resistant and does not participate in screening visits to gynaecologists in the long term. A significant proportion of such women, however, regularly visit their general practitioner due to other comorbidities. The aim of the ASTRA project is to assess whether an effective way to increase the proportion of women attending cervical screening is to perform self-testing for HPV DNA in the GP's office."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women over 30 years of age who meet the entry criteria for inclusion in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent for statistical data processing and consent to the processing of personal data\n* Age 30+\n* HPV test never performed or performed more than 3 years ago or patient does not know\n\nExclusion Criteria:\n\n* Refusal to participate\n* Pregnancy and puerperium\n* Menses\n* History of hysterectomy\n* HPV test performed \\<3 years ago with negative result\n* Regular participation in screening and concurrent age 35, 45 or 55 years (test will be performed in the same year of screening).'}, 'identificationModule': {'nctId': 'NCT06253169', 'acronym': 'ASTRA', 'briefTitle': "HPV DNA Self-sampling in a General Practitioner's Office.", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Patient Organization Veronica'}, 'officialTitle': "Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.", 'orgStudyIdInfo': {'id': 'V01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Not participating in screening', 'description': 'All women over 30 years of age who are not participating in screening or have not had a screening visit in less than 5 years.', 'interventionNames': ['Diagnostic Test: HPV DNA self-test']}, {'label': 'Participating in the screening', 'description': 'All women over 30 years of age who regularly participate in screening but have not had an HPV test in the last 3 years.', 'interventionNames': ['Diagnostic Test: HPV DNA self-test']}], 'interventions': [{'name': 'HPV DNA self-test', 'type': 'DIAGNOSTIC_TEST', 'description': 'HPV DNA swab from the cervix performed by the patient herself.', 'armGroupLabels': ['Not participating in screening', 'Participating in the screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12000', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Lucie Panýrová, PhD', 'role': 'CONTACT', 'email': 'lucie.panyrova@next-clinics.com', 'phone': '+420 603 509 151'}, {'name': 'Jiří Sláma, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lucie Mandelová, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CGOP, s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '12000', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jiří Sláma, MD PhD', 'role': 'CONTACT', 'email': 'jiri.slama@vfn.cz', 'phone': '+420224967451'}, {'name': 'Jiří Sláma, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Jiří Sláma, MD, PhD', 'role': 'CONTACT', 'email': 'jiri.slama@vfn.cz', 'phone': '+420224967451'}], 'overallOfficials': [{'name': 'Veronika Cibulová, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Patient Organisation Veronica'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All anonymised data will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patient Organization Veronica', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}