Clinical trial · Observational
Incidence of Cervical Cancer in HPV-positive Women With Low-grade Cytological Abnormalities
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervix Carcinoma | Cervical Carcinoma | ALIAS | 0.90 |
| Cervix; Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervix Uteri Cancer | Cervical Neoplasm | PROBABILISTIC | 0.70 |
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort low-grade cytological abnormalities
- description
- 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.
- label
- Cohort HPV positive and no cervical abnormalities
- description
- 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.
Primary outcomes (1)
- measure
- Five-year incidence cervical cancer
- timeFrame
- From enrollment up to 5 years after.
- description
- Incidence of histologically confirmed cervical cancer within the five-year screening interval.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: Women who participated in the cervical cancer screening program in the Netherlands between January 2017 and December 2018, who: * Tested HPV-positive with 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) according to the Bethesda system, or * Were HPV-positive and had stable negative for intra-epithelial leasion or malignancy (NILM) cytology after one year. Exclusion Criteria: * None
References
Publications (14)
- BACKGROUNDCervical cancer screening programme. RIVM n.d. https://www.rivm.nl/en/cervical- cancer-screening-programme (accessed June 1, 2025).
- BACKGROUNDWHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention n.d. https://www.who.int/publications/i/item/9789240030824 (accessed June 1, 2025).
- BACKGROUNDEramus MC, Palga. Bevolkingsonderzoek Baarmoederhalskanker - Monitor 2017. RIVM 2017.
- BACKGROUNDThe Netherlands: Integraal Kankercentrum Nederland. National Guidelines: CIN, AIS en VAIN (Dutch). Richtlijnendatabase Federatie Medisch Specialisten;Accessed June 2025.
- BACKGROUNDThe Netherlands: Integraal Kankercentrum Nederland. National Guidelines: Cervixcytologie- Codering van de uitslag (Dutch). Richtlijnendatabase Federatie Medisch Specialisten; Accessed June 2025.
- BACKGROUNDSharp L, Cotton S, Cruickshank M, Gray NM, Harrild K, Smart L, Walker LG, Little J; TOMBOLA Group. The unintended consequences of cervical screening: distress in women undergoing cytologic surveillance. J Low Genit Tract Dis. 2014 Apr;18(2):142-50. doi: 10.1097/LGT.0b013e31829c97d8. PMID 24270192
- BACKGROUNDKatki HA, Gage JC, Schiffman M, Castle PE, Fetterman B, Poitras NE, Lorey T, Cheung LC, Raine-Bennett T, Kinney WK. Follow-up testing after colposcopy: five-year risk of CIN 2+ after a colposcopic diagnosis of CIN 1 or less. J Low Genit Tract Dis. 2013 Apr;17(5 Suppl 1):S69-77. doi: 10.1097/LGT.0b013e31828543b1. PMID 23519308
- BACKGROUNDCiavattini A, Serri M, Di Giuseppe J, Liverani CA, Gardella B, Papiccio M, Delli Carpini G, Morini S, Clemente N, Sopracordevole F. Long-term observational approach in women with histological diagnosis of cervical low-grade squamous intraepithelial lesion: an Italian multicentric retrospective cohort study. BMJ Open. 2019 Jul 3;9(7):e024920. doi: 10.1136/bmjopen-2018-024920. PMID 31272971