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| Name | Class |
|---|---|
| PALGA foundation | OTHER |
| Amphia Hospital | OTHER |
| Maastricht University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort low-grade cytological abnormalities | 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. | ||
| Cohort HPV positive and no cervical abnormalities | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Five-year incidence cervical cancer | Incidence of histologically confirmed cervical cancer within the five-year screening interval. | From enrollment up to 5 years after. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to diagnosis of cervical carcinoma | Time from enrollment to diagnosis of cervical carcinoma | 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. |
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Inclusion Criteria:
Women who participated in the cervical cancer screening program in the Netherlands between January 2017 and December 2018, who:
Exclusion Criteria:
Women/people who have a cervix.
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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.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Cervical cancer screening programme. RIVM n.d. https://www.rivm.nl/en/cervical- cancer-screening-programme (accessed June 1, 2025). | ||
| Background | WHO 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). | ||
| Background | Eramus MC, Palga. Bevolkingsonderzoek Baarmoederhalskanker - Monitor 2017. RIVM 2017. | ||
| Background | The Netherlands: Integraal Kankercentrum Nederland. National Guidelines: CIN, AIS en VAIN (Dutch). Richtlijnendatabase Federatie Medisch Specialisten;Accessed June 2025. | ||
| Background | The Netherlands: Integraal Kankercentrum Nederland. National Guidelines: Cervixcytologie- Codering van de uitslag (Dutch). Richtlijnendatabase Federatie Medisch Specialisten; Accessed June 2025. | ||
| 24270192 |
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We do not have ownership of the individual participant data. Data can be obtained on request at https://aanvraag.palga.nl/login
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2025 | Nov 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| 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 | Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after. |
| Carcinoma subtype | Histological characteristics of carcinoma (subtype). | 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 +). | From enrollment up to 5 years after. |
| Background |
| Sharp 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. |
| 23519308 | Background | Katki 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. |
| 31272971 | Background | Ciavattini 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. |
| 7791229 | Background | Bosch FX, Manos MM, Munoz N, Sherman M, Jansen AM, Peto J, Schiffman MH, Moreno V, Kurman R, Shah KV. Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst. 1995 Jun 7;87(11):796-802. doi: 10.1093/jnci/87.11.796. |
| 31980322 | Background | Jansen EEL, Zielonke N, Gini A, Anttila A, Segnan N, Voko Z, Ivanus U, McKee M, de Koning HJ, de Kok IMCM; EU-TOPIA consortium. Effect of organised cervical cancer screening on cervical cancer mortality in Europe: a systematic review. Eur J Cancer. 2020 Mar;127:207-223. doi: 10.1016/j.ejca.2019.12.013. Epub 2020 Jan 21. |
| 30140883 | Background | Melnikow J, Henderson JT, Burda BU, Senger CA, Durbin S, Weyrich MS. Screening for Cervical Cancer With High-Risk Human Papillomavirus Testing: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Aug 21;320(7):687-705. doi: 10.1001/jama.2018.10400. |
| 30140884 | Background | US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 21;320(7):674-686. doi: 10.1001/jama.2018.10897. |
| 35839811 | Background | Bruni L, Serrano B, Roura E, Alemany L, Cowan M, Herrero R, Poljak M, Murillo R, Broutet N, Riley LM, de Sanjose S. Cervical cancer screening programmes and age-specific coverage estimates for 202 countries and territories worldwide: a review and synthetic analysis. Lancet Glob Health. 2022 Aug;10(8):e1115-e1127. doi: 10.1016/S2214-109X(22)00241-8. |
| 31812369 | Background | Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |