HPV Integration Testing for Cervical Cancer Screening

NCT02576158 | Unknown

• 1 other identifier: CCS-01
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT

  14 Months

Study Arms (1)

Subjects will be women, 30-65 years of age

Patients who are at average risk of developing cervical intraepithelial neoplasia or cervical cancer 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. Subjects with HPV positive will undergo colposcopy within 90 days of enrollment.

Procedure: TCT，HPV，colposcopic inspection

Interventions

TCT，HPV，colposcopic inspection PROCEDURE

Subjects will be women, 30-65 years of age

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy women between the ages of 30 and 65 years

You may qualify if:

• Women aged 30-65 years old Attending the China population-based organised cervical screening program

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

• Huazhong University of Science and Technology: lead

Study Sites (1)

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

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; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Ding Ma, MD, PhD

  Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Danhui Weng, MD, PhD

CONTACT

+862783662681; weng.dh@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 15, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: April 1, 2020
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

CN (1)