Clinical trial NCT06082765: Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Official title: Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Keywords: HPV
menstrual blood
cervical cancer
screening,
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Central Hospital
name: Huanggang Maternal and Child Health Hospital
name: Guilin People's Hospital
name: Zaoyang Maternal and Child Health Hospital
name: Jingshan People's Hospital
name: Yichang Second People's Hospital
name: Wuhan Third People's Hospital
name: Dawu County People's Hospital
name: Yingshan County People's Hospital
name: Zhongxiang People's Hospital
name: Zhongxiang Maternal and Child Health Hospital
name: Wuxue First People's Hospital
name: The First People's Hospital of Tianmen
name: Huangmei County People's Hospital
name: Huangmei Maternal and Child Health Care Hospital
name: Gucheng County People's Hospital
First posted: 2023-10-13
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study is designed as a two-phase study. The phase I aims to recruit 5,000 women to explore the application value of HPV detection in menstrual blood using next-generation sequencing. The phase II aims to recruit 5,000 women to evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling.

Brief summary: Our study is a population-based, cross-sectional study. This study is conducted to recruit cervical cancer screening participants to evaluate the application value of using high-throughput sequencing technology to detect HPV in menstrual blood for cervical cancer screening. Our study is designed as a two-phase study :

Phase I : This phase, which will be preparing to recruit 5,000 participants, evaluates the accuracy of menstrual blood (MB) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+) in the general population, with a secondary objective to evaluate the Minipad as a special device to collect MB.

Phase II : This phase, which will continue to recruit toward the 10,000-participant target, will evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling. This phase aims to further reduce unnecessary colposcopies while maintaining high sensitivity for CIN2+ detection.

Detailed description: Our study will recruit 10,000 participants for cervical cancer screening across seven sites in Hubei Province from September 1, 2023, to March 31, 2028. The participating sites include: Fruit Lake Community (where Zhongnan Hospital of Wuhan University is located), Jiang'an District (Wuhan Central Hospital), Huangzhou district of Huanggang County (Huanggang Maternal and Child Health Care Hospital), Jingling Community of Tianmen County (the First People's Hospital of Tianmen), Liutang Community of Huangmei County (Huangmei County People's Hospital), Gongtang Community of Zhongxiang City (Zhongxiang Maternal and Child Health Care Hospital), and Chaihu Community of Zhongxiang City (People's Hospital of Zhongxiang).. The procedures were conducted as below: (1) Conduct cervical cancer screening (TCT+hr-HPV) for all the participants. (2) Collect sanitary napkins from participants during their first menstrual period after cervical HPV testing. (3) Detect HPV using high-throughput sequencing technology in the menstrual blood (MB) from sanitary napkins. (4) Colposcopy referral (biopsy if necessary) for patients with abnormal screening results. (5) Compare the concordance between MB-HPV and clinician-collected HPV. (6) Evaluate the accuracy of menstrual blood (MB) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+) in the general population, with a secondary objective to evaluate the Minipad as a special device to collect MB. (7) Evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling.

Eligibility criteria: Inclusion Criteria:

1. plan to undergo cervical screening
2. with regular menstruation (21-35 days)
3. agree to participate in this study and have signed an informed consent form

Exclusion Criteria:

1. with amenorrhea or menopause
2. suffering from genital tract infection
3. refuse to participate in this study

Primary outcomes:
measure: HPV detection in menstrual blood
timeFrame: December 31, 2025
Secondary outcomes:
measure: HPV detection in menstrual blood
timeFrame: December 31, 2025
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Gynecologic Oncology
state: Hubei
Study officials:
affiliation: Zhongnan Hospital
name: Zheng Hu, doctor
role: PRINCIPAL_INVESTIGATOR
References: