Infections

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Rare Diseases

Uterine Cervical Neoplasms

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Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Sexually Transmitted Diseases, Viral

Virus Diseases

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Disease Attributes

Precancerous Conditions

Cervical Intraepithelial Neoplasia

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.

HPV integration test

Ting Hu, MD, PhD

Ting Hu, MD,PhD

Ding Ma, MD, PhD

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.

Based on the dilemma of the cervical cancer screening process, in the last five years, our team developed a novel cervical cancer triage strategy and conducted a large cohort study, which evaluated the clinical performance of HPV integration triage alone and in combination with HPV16/18 or HPV16 genotyping of HPV-positive women. We found that the specificity of HPV integration for greater than cervical intraepithelial neoplasia 3 was 94.5%, which was significantly higher than that of cytology (63.8%; P \< 0.001) in our previous retrospective study.Here, we conducted a large prospective cohort study evaluating the clinical performance of HPV integration triage of HPV-positive women.

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

Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women：a Prospective Cohort Study

CIN2+ diagnosed on biopsy obtained at colposcopy.

CIN3+ diagnosed on biopsy obtained at colposcopy.

Ding Ma

Chairman of Obstetrics & Gynecology department of Tongji hospital

The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women	NCT05570331	HPV Infection Cervical Cancer	HPV integration...	20 Years - 70 Years	Tongji Hospital
The Predictive Role of HPV Integration in HSIL and Cervical Cancer	NCT05300243	HPV Integration	HPV integration...	18 Years - 70 Years	Tongji Hospital

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