Karolinska University Hospital
Stockholm, 14186, Sweden
NCT Number: NCT05709730
The purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality.
This study is active but is not currently recruiting participants.
23 year–80 year
Female
Observational
Stockholm, 14186, Sweden
The aim of the study is to clarify whether follow-up of cell changes is carried out with sufficiently good quality. It is nationally recommended to perform an HPV test on mild cell changes and only refer to clinical follow-up if you are HPV positive. Descriptive statistics on HPV-testing and follow-up of quality are not available today. If HPV testing has not already been performed, archived samples with glandular cell changes will be HPV-analyzed in Cobas 4800 HPV-polymerase chain reaction (PCR), which shows data on the presence of HPV and Luminex-PCR, which shows which HPV types the samples have. Women with low-grade squamous cell changes (ASCUS and CIN1) with simultaneous HPV analysis will be followed up with data from the Swedish National Cervical Screening Registry (NKCx) from the last ten years. A register linkage with data from NKCx and the National Cancer Registry at the National Board of Health and Welfare will be carried out to determine which women have developed gynecological cancer, cervical cancer and/or pre-cancer (cancer in situ). A follow-up review of reported original cytological (cell samples) and histological (tissue samples) diagnoses will be performed by cytodiagnostics and cytopathologists, to verify the correct diagnosis.
Statistics on collection of non-organized cell samples after a partial negative sample where follow-up is not recommended are produced in aggregated form in the form of an extract from NKCx
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
HPV genotyping of samples classified that were positive for "other HPV"
Time frame: 2014-2018
Risk for developing CIN3+ or worse depending on HPV type
Karolinska University Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05179824
Adnexal Diseases, Bile Duct Diseases
Dallas, Texas, United States
View Trial DetailsNCT06786429
Adenocarcinoma, Anxiety Disorders
View Trial DetailsNCT06147960
Apoptosis, Cancer of Cervix
Nîmes, Gard, France
View Trial DetailsNCT03452774
Adenocarcinoma, Adnexal Diseases
Birmingham, Alabama, United States
View Trial Details