Evaluation of Digital Cytology for the Triage of HPV-positive Women in a Same-day "Test-triage-treat" Cervical Cancer Screening Strategy in Cameroon
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of HPV-based screening with digital cytology triage for detection of CIN2+
研究概览
简要总结
This study evaluates the diagnostic accuracy and feasibility of a same-day cervical cancer screening strategy using HPV self-sampling followed by digital telecytology triage among HPV-positive women in Cameroon. Women aged 30-49 years (or 25-49 years if HIV-positive) will undergo primary HPV testing using the GeneXpert system. HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including immediate treatment, telecytology triage, or follow-up. Histological assessment serves as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary objectives include evaluation of AI-assisted telecytology and visual inspection with acetic acid (VIA), as well as the acceptability of screening and treatment strategies among women and healthcare providers. The study aims to generate evidence to support scalable, WHO-recommended test-triage-treat approaches in low-resource settings
详细描述
This study is a prospective, single-center diagnostic accuracy and feasibility study conducted at the Yaoundé University Hospital in Cameroon. It evaluates a same-day cervical cancer screening strategy based on primary HPV testing with self-sampling, followed by triage using extended HPV genotyping and digital telecytology among HPV-positive women, within a test-triage-treat approach.
Women aged 30 to 49 years, and HIV-positive women aged 25 to 49 years, will be invited to participate following community-based awareness activities and hospital-based recruitment. After providing written informed consent, participants will perform HPV self-sampling. Primary screening will be conducted using the GeneXpert system, which provides rapid detection and genotyping of oncogenic HPV types.
Management of HPV-positive women will follow a predefined algorithm based on extended HPV genotyping. Women positive for HPV type 16 will be considered for immediate treatment following clinical assessment. Women positive for HPV types 18, 45, 31, 33, 35, 52, or 58 will undergo same-day triage using digital telecytology. Women positive for HPV types 51, 59, 39, 56, 66, or 68 will be scheduled for follow-up without immediate treatment unless clinically indicated.
For triage procedures, all HPV-positive women will undergo visual inspection with acetic acid (VIA), cervical cytology, and endocervical sampling, with either a VIA-directed biopsy or a random biopsy of the transformation zone, as appropriate. Cytology slides will be prepared locally and digitized for remote interpretation by trained cytopathologists. Women with cytological abnormalities of atypical squamous cells of undetermined significance (ASC-US) or worse will be offered same-day treatment with thermal ablation. Histological assessment of endocervical samples and biopsies will serve as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).
Artificial intelligence-assisted telecytology and AI-assisted VIA will be evaluated as secondary diagnostic tools. These AI-based analyses will not be used for clinical decision-making but will be assessed retrospectively to determine their diagnostic performance and concordance with standard interpretation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV-negative women aged 30-49 and HIV-positive women aged 25-49 years old
- •Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).
排除标准
- •Pregnancy at the time of screening
- •Previous hysterectomy
- •Known cervical cancer
- •Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
- •Conditions that can interfere with visualization of the cervix
- •Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)
- •Women who are not able to comply with the study protocol.
研究组 & 干预措施
HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy
Participants undergo primary HPV testing using self-collected vaginal samples with extended genotyping. Management is based on HPV genotype within a predefined test-triage-treat strategy:
- Women positive for HPV16 receive immediate treatment with thermal ablation.
- Women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo triage with digital telecytology. If cytology results are abnormal (≥ ASC-US), treatment with thermal ablation is provided.
- Women positive for HPV types 51, 59, 39, 56, 66, or 68 are managed with follow-up at 12 months without immediate treatment.
All HPV-positive women undergo endocervical sampling and biopsy, as the reference standard for diagnostic evaluation.
干预措施: HPV testing (self-sampling) (Diagnostic Test)
HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy
Participants undergo primary HPV testing using self-collected vaginal samples with extended genotyping. Management is based on HPV genotype within a predefined test-triage-treat strategy:
- Women positive for HPV16 receive immediate treatment with thermal ablation.
- Women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo triage with digital telecytology. If cytology results are abnormal (≥ ASC-US), treatment with thermal ablation is provided.
- Women positive for HPV types 51, 59, 39, 56, 66, or 68 are managed with follow-up at 12 months without immediate treatment.
All HPV-positive women undergo endocervical sampling and biopsy, as the reference standard for diagnostic evaluation.
干预措施: Digital telecytology (Diagnostic Test)
HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy
Participants undergo primary HPV testing using self-collected vaginal samples with extended genotyping. Management is based on HPV genotype within a predefined test-triage-treat strategy:
- Women positive for HPV16 receive immediate treatment with thermal ablation.
- Women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo triage with digital telecytology. If cytology results are abnormal (≥ ASC-US), treatment with thermal ablation is provided.
- Women positive for HPV types 51, 59, 39, 56, 66, or 68 are managed with follow-up at 12 months without immediate treatment.
All HPV-positive women undergo endocervical sampling and biopsy, as the reference standard for diagnostic evaluation.
干预措施: AI-assisted telecytology (Diagnostic Test)
HPV-based screening with digital telecytology triage in a same-day test-triage-treat strategy
Participants undergo primary HPV testing using self-collected vaginal samples with extended genotyping. Management is based on HPV genotype within a predefined test-triage-treat strategy:
- Women positive for HPV16 receive immediate treatment with thermal ablation.
- Women positive for HPV types 18, 31, 33, 35, 45, 52, or 58 undergo triage with digital telecytology. If cytology results are abnormal (≥ ASC-US), treatment with thermal ablation is provided.
- Women positive for HPV types 51, 59, 39, 56, 66, or 68 are managed with follow-up at 12 months without immediate treatment.
All HPV-positive women undergo endocervical sampling and biopsy, as the reference standard for diagnostic evaluation.
干预措施: Thermal ablation (Procedure)
结局指标
主要结局
Diagnostic accuracy of HPV-based screening with digital cytology triage for detection of CIN2+
时间窗: At baseline (initial screening visit)
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios of HPV testing with digital cytology triage for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+), using histology as the reference standard.
次要结局
- Feasibility of same-day test-triage-treat strategy(At baseline (same-day visit))
- Diagnostic performance of AI-assisted telecytology for detection of CIN2+(At baseline)
- Detection rate of CIN2+ using AI-assisted VIA(At baseline)
- Agreement between digital cytology and AI-assisted cytology(At baseline)
- Acceptability of HPV-based screening and triage strategy(During study period (up to 26 months))
研究者
Prof. Patrick Petignat
Head of the Gynecologic Division
University Hospital, Geneva