An observational study in Cervical Intraepithelial Neoplasia, Cervix Uteri Cancer and Human Papilloma Virus, sponsored by Gynaecologisch Oncologisch Centrum Zuid. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Gynaecologisch Oncologisch Centrum Zuid · Observational
The goal of this observational study is to assess the five-year incidence of histologically confirmed cervical cancer among women who test positive for human papillomavirus (HPV) with low-grade cytological abnormalities, to evaluate whether follow-up intensity could be reduced in women participating in the Dutch population-based cervical cancer screening program who are HPV-positive and have low-grade cytological abnormalities - atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesions (LSIL).
The main questions it aims to answer are:
What is the five-year risk of developing cervical cancer in HPV-positive women with low-grade cytological abnormalities?
Does the presence of subsequent low-grade cytology affect the five-year risk of cervical cancer in this population?
Researchers will compare the risk of cervical cancer in HPV-positive women with low-grade abnormalities to women with stable negative for intraepithelial lesion or malignancy (NILM) cytology, since women with stable NILM are discharged from further follow-up back to the screening programme. This will help evaluate whether follow-up intensity can be reduced in women with low-grade abnormalities.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's enrollment of 46,079 is above the median of 435 across 110 observational studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Gynaecologisch Oncologisch Centrum Zuid is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This retrospective cohort study included women who participated in the population-based cervical cancer screening program in the Netherlands between January 2017 and December 2018. Eligible participants were HPV-positive and had cytology results categorized as atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesion (LSIL) or stable negative for intra-epithelial leasion or malignancy (NILM) cytology results after one year according to the Bethesda system.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women who participated in the cervical cancer screening program in the Netherlands between January 2017 and December 2018, who:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women who participated in the population-based cervical cancer screening program in the Netherlands between January 2017 and December 2018 who were HPV positive and with cytology results atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesion (LSIL) according to the Bethesda system.
Women who participated in the population-based cervical cancer screening program in the Netherlands between January 2017 and December 2018 who were HPV positive and with a stable cytology result negative for intra-epithelial neoplasia according to the Bethesda system.
Five-year incidence cervical cancer
Incidence of histologically confirmed cervical cancer within the five-year screening interval.
Time frame: From enrollment up to 5 years after.
Time to diagnosis of cervical carcinoma
Time from enrollment to diagnosis of cervical carcinoma
Time frame: From enrollment up to 5 years after.
All-cause mortality
The number of participants that died from enrollment up to five years after, all causes of death included.
Time frame: From enrollment up to 5 years after.
Examination at which the diagnosis cervical carcinoma was established
Type of examination at which the diagnosis was established
Time frame: Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after.
Carcinoma subtype
Histological characteristics of carcinoma (subtype).
Time frame: Moment of diagnosis of cervical carcinoma within 5 years after enrollment.
Incidence of cervical cancer within 5 years of inclusion stratified by histological diagnosis within three months of enrollment
Incidence of cervical cancer within 5 years of inclusion stratified by histological diagnosis within three months of baseline abnormal cytology (≤ CIN I vs CIN 2+) and, for the ≤ CIN I group, fur-ther stratified by cytology at 12-month follow-up (no or nondiagnostic cytology, ≤ LSIL, HSIL +).
Time frame: From enrollment up to 5 years after.
No study locations are listed for this record.
Plan to share: No — The investigators do not have ownership of the individual participant data. Data can be obtained on request at https://aanvraag.palga.nl/login
Ran from Jan 2017 to primary completion in Dec 2023, 83 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Gynaecologisch Oncologisch Centrum Zuid