- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04909814
Colposcopic Impression in a Birth Cohort Previously Eligible for HPV-vaccination
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To describe the source population, the overall number of invitations and tests taken in the region during the study period were retrieved from the Swedish National Cervical Screening Registry (NKCx), which has an almost 100% coverage of screening history in Sweden since 1993.
Women were invited to attend colposcopy within two-four months after a positive screening test (two consecutive screening tests indicating low-grade squamous intraepithelial lesions (LSIL) and HPV positivity or a single screening test indicating high grade squamous intraepithelial lesions (HSIL)), according to national guidelines. All colposcopies were performed in 2018 and 2019 at the Department of Obstetrics and Gynecology, Falun Hospital, by a specialist in Obstetrics and Gynecology. Digital imaging ensured the possibility of subsequent re-review by an expert colposcopist at the Karolinska University Hospital. The colposcopies consisted of a microscopic evaluation of the uterine cervix including punch biopsies as well as endocervical sampling with liquid based cytology (LBC). In the absence of visible colposcopic lesions, random biopsies at 6 and 12 o´clock were taken to ensure histopathological confirmation in all women. Women with colposcopic and/or histopathologic findings that required treatment underwent excision (conization) according to national guidelines. The consultation also included questions on medical history according to a protocol designed for the study.
Analysis of histopathology and cytology was performed at the Department of Pathology, Falun Hospital. An LBC sample was analyzed for the presence of 14 high risk HPV (hrHPV) genotypes and cytology. HPV samples were tested at the Department of Laboratory Medicine, Falun Hospital, using amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization (Cobas 4800, Roche Molecular Systems). LBC samples positive for high risk types other than HPV 16/18, were sent for further genotyping to the Center for Cervical Cancer Prevention at the Karolinska University Laboratory Huddinge.
Information on vaccination status was retrieved through linkage to the National HPV Vaccination Register (SVEVAC), an informed consent-based register in operation since the introduction of HPV vaccination In Sweden, and data was further complemented by linkage to the Prescribed Drug Register (PDR), a mandatory register on dispensed prescriptions in Sweden in operation since July 2005. All women were asked about their vaccination status after the colposcopic examination had been performed, and linkage to SVEVAC and PDR was run after all study colposcopies and laboratory analysis had been completed. Hence, vaccination status was blinded to the colposcopists, pathologists, and laboratory staff.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Dalarna
-
Falun, Dalarna, Sweden, 79172
- Falu lasarett
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- HPV-vaccinated women Women taking their first test within the organized cervical screening program at age 23 Women residing in one Swedish county
Exclusion Criteria:
Women who were hysterectomized, Women who died Women who moved
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vaccinated women with positive screening test
All women in one Swedish county taking their first screening test within the organized cervical screening program
|
Evaluating the performance of colpscopy in HPV vaccinated women by comparing vaccinated and unvaccinated women taking their first test within the organized screening program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of the Swedscore colposcopy scale in HPV-vaccinated women
Time Frame: 1 year
|
Positive predictive value of colposcopy for high grade lesions in HPV-vaccinated women
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/535-31/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
National Cancer Institute (NCI)Gynecologic Oncology Group; NCIC Clinical Trials GroupTerminatedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Cervical Adenosquamous Cell CarcinomaUnited States, Canada
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
Clinical Trials on The performance of colposcopy in vaccinated women
-
Universidad de GranadaUnknownPregnant Woman With Single Pregnancy | Pregnant Woman With no Assisted ReproductionSpain
-
Kanuni Sultan Suleyman Training and Research HospitalNot yet recruiting
-
Econometría ConsultoresInter-American Development BankSuspendedViolence Against Women (VAW)Colombia
-
Ginekološka Poliklinika Dr. Vesna HarniUniversity of Zagreb; Klinički Bolnički Centar ZagrebCompletedLichen Planus | Lichen Sclerosus | Vulvodynia | Lichen Simplex ChronicusCroatia
-
Universidad de MurciaUniversidad Católica San Antonio de MurciaCompletedPerformance | Sports Physical Therapy | AthleticsSpain
-
Jagiellonian UniversityCompletedPolycystic Ovary Syndrome | Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)Poland
-
University of PadovaAzienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine... and other collaboratorsCompletedPregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy
-
Soroka University Medical CenterCompletedGestational Diabetes Mellitus
-
Gerencia de Atención Primaria, MadridFundación de Innovación e Investigación Biomédica de Atención Primaria-MadridCompleted
-
Institut de Médecine et d'Epidémiologie Appliquée...ANRS, Emerging Infectious DiseasesRecruitingChlamydia Trachomatis Infection | Mycoplasma Genitalium Infection | Neisseria Gonorrhoeae Infection | Sexually Transmitted Infections (Not HIV or Hepatitis)France