Cervical Intraepithelial NeoplasiaNCT07259616
Incidence of Cervical Cancer in HPV-positive Women With Low-grade Cytological Abnormalities
An observational study of Cervical Intraepithelial Neoplasia and Cervix Uteri Cancer, run by Gynaecologisch Oncologisch Centrum Zuid.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervix Uteri Cancer, Human Papilloma Virus
- How many people
- 46,079 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- None
About this study
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:
Read more
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
- Cervical Intraepithelial Neoplasia, Cervix Uteri Cancer, Human Papilloma Virus, Cervix Carcinoma, Cervix; Intraepithelial Neoplasia
- Keywords
- Human papilloma virus, Cervical cancer, Low-grade cytological abnormalities, Cervical cancer screening, Retrospective cohort study, Five-year incidence
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year incidence cervical cancer
Incidence of histologically confirmed cervical cancer within the five-year screening interval.
Measured: From enrollment up to 5 years after.
Secondary outcomes (5)
Time to diagnosis of cervical carcinoma
Time from enrollment to diagnosis of cervical carcinoma
Measured: 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.
Measured: 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
Measured: Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after.
Carcinoma subtype
Histological characteristics of carcinoma (subtype).
Measured: 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 +).
Measured: From enrollment up to 5 years after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynaecologisch Oncologisch Centrum Zuid
- Sponsor type
- University, hospital or other
- Collaborators
- PALGA foundation, Amphia Hospital, Maastricht University
- Responsible party
- Principal investigator, Jurgen M.J. Piek, Gynaecologisch Oncologisch Centrum Zuid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259616
- Sponsor's protocol ID
- GOCZ
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not have ownership of the individual participant data. Data can be obtained on request at https://aanvraag.palga.nl/login
Publications
Cervical cancer screening programme. RIVM n.d. https://www.rivm.nl/en/cervical- cancer-screening-programme (accessed June 1, 2025).
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).
Eramus MC, Palga. Bevolkingsonderzoek Baarmoederhalskanker - Monitor 2017. RIVM 2017.
The Netherlands: Integraal Kankercentrum Nederland. National Guidelines: CIN, AIS en VAIN (Dutch). Richtlijnendatabase Federatie Medisch Specialisten;Accessed June 2025.
The Netherlands: Integraal Kankercentrum Nederland. National Guidelines: Cervixcytologie- Codering van de uitslag (Dutch). Richtlijnendatabase Federatie Medisch Specialisten; Accessed June 2025.
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.
PubMed 24270192Katki 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.
PubMed 23519308Ciavattini 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.
PubMed 31272971Bosch 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.
PubMed 7791229Jansen 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.
PubMed 31980322Melnikow 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.
PubMed 30140883US 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.
PubMed 30140884Bruni 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.
PubMed 35839811Arbyn 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.
PubMed 31812369
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Cervical Cancer in HPV-positive Women With Low-grade Cytological Abnormalities
- ClinicalTrials.gov ID
- NCT07259616
- Acronym / sponsor ID
- GOCZ
- Conditions
- Cervical Intraepithelial Neoplasia, Cervix Uteri Cancer, Human Papilloma Virus, Cervix Carcinoma, Cervix; Intraepithelial Neoplasia
- Keywords
- Human papilloma virus, Cervical cancer, Low-grade cytological abnormalities, Cervical cancer screening, Retrospective cohort study, Five-year incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46,079 participants (actual)
- Lead sponsor
- Gynaecologisch Oncologisch Centrum ZuidUniversity, hospital or other
- Collaborators
- PALGA foundation, Amphia Hospital, Maastricht University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Five-year incidence cervical cancer
Time frame: From enrollment up to 5 years after.
Incidence of histologically confirmed cervical cancer within the five-year screening interval.
5 secondary outcomes
Time to diagnosis of cervical carcinoma
Time frame: From enrollment up to 5 years after.
All-cause mortality
Time frame: From enrollment up to 5 years after.
Examination at which the diagnosis cervical carcinoma was established
Time frame: Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after.
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
Time frame: From enrollment up to 5 years after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- 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.
- Background: PubMed 24270192Sharp 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.
- Background: PubMed 23519308Katki 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.
- Background: PubMed 31272971Ciavattini 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.
- Background: PubMed 7791229Bosch 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.
- Background: PubMed 31980322Jansen 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.
- Background: PubMed 30140883Melnikow 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.
- Background: PubMed 30140884US 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.
- Individual participant dataSharing planned: No. The investigators 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia and Cervix Uteri Cancer, run by Gynaecologisch Oncologisch Centrum Zuid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year incidence cervical cancer (time frame: From enrollment up to 5 years after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07259616, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.