Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women

NCT05570331 | Unknown

• 1 other identifier: TJ-IRB20220142
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

Conditions

HPV Infection; Cervical Cancer

Keywords

Cervical cancer screening, HPV test, HPV integration

Outcome Measures

Primary Outcomes (2)

• Risk of CIN2+ disease

  CIN2+ diagnosed on biopsy obtained at colposcopy.

  3 years

• Risk of CIN3+ disease

  CIN3+ diagnosed on biopsy obtained at colposcopy.

  3 years

Interventions

HPV integration test DIAGNOSTIC_TEST

HPV-positive patients who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

aged 20y-70y HPV-positive women

You may qualify if:

• Consenting women aged 20y-70y with HPV-positive results

You may not qualify if:

• Not providing informed consent
• previously confirmed CIN, cervical cancer, or other malignancies
• previous therapeutic procedure to cervix
• pregnancy

Sponsors & Collaborators

• Ding Ma: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cervical Exfoliated Cells sample

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Ding Ma, MD, PhD

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Ting Hu, MD, PhD

CONTACT

862783662681; cat_huting@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Obstetrics & Gynecology department of Tongji hospital

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 6, 2022
• Study Start: January 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: December 31, 2025
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

CN (1)