Cervical Intraepithelial Neoplasia, Cervix Carcinoma, Cervix; Intraepithelial Neoplasia, Cervix Uteri Cancer, Human Papilloma Virus
Conditions
Keywords
Human papilloma virus, Cervical cancer, Low-grade cytological abnormalities, Cervical cancer screening, Retrospective cohort study, Five-year incidence
Brief 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 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.
Interventions
None listed
Sponsors
Gynaecologisch Oncologisch Centrum Zuid
PALGA foundation
Amphia Hospital
Maastricht University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Five-year incidence cervical cancer | From enrollment up to 5 years after. | Incidence of histologically confirmed cervical cancer within the five-year screening interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to diagnosis of cervical carcinoma | From enrollment up to 5 years after. | Time from enrollment to diagnosis of cervical carcinoma |
| All-cause mortality | From enrollment up to 5 years after. | The number of participants that died from enrollment up to five years after, all causes of death included. |
| Examination at which the diagnosis cervical carcinoma was established | Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after. | Type of examination at which the diagnosis was established |
| Carcinoma subtype | Moment of diagnosis of cervical carcinoma within 5 years after enrollment. | Histological characteristics of carcinoma (subtype). |
| Incidence of cervical cancer within 5 years of inclusion stratified by histological diagnosis within three months of enrollment | From enrollment up to 5 years after. | 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 +). |
Outcome results
None listed