The study on the treatment strategies and accurate prediction models for high-risk human papillomavirus 16/18-positive LSIL patients

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085381

Enrollment

Unknown

Registered

2024-06-06

Start date

2024-07-01

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical intraepithelial neoplasia

Interventions

LEEP surgery/photodynamic therapy: LEEP surgery or photodynamic therapy

follow-up group:Regular follow-up, semi-annual follow of HPV+TCT, and annual colposcopy biopsy

Eligibility

Sex/Gender

Female

Age

40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Women aged = 40 who have completed childbirth; (2) LSIL lesions limited to the cervix were confirmed by the histopathological examination of the colposcopy tissue in our research institution, and the pathological grade of cervical scraping was less than CIN 2; (3) HPV16 and/or type 18 positivity detected for the first time; (4) Liquid based cytology (TCT) is limited to: NILM, ASC-US, LSIL; (5) Clarify no fertility requirements; (6) Sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) has atypical glandular hyperplasia with unclear significance or glandular cell abnormalities that require immediate examination; (2) has intraepithelial neoplasia of the external genitalia or vagina; (3) has vaginal genital warts; (4) Previously received treatment, including pelvic and abdominal radiation therapy, chemotherapy, and surgical procedures (laser, electrocauterization or cryotherapy); (5) Previous history of gynecological malignancies, as well as other malignant tumors other than skin cancer that is not melanoma; (6) Immunosuppression due to AIDS, organ transplantation and other diseases or immunosuppressive drugs; (7) In the follow-up of LSIL confirmed by biopsy; (8) Unable to participate in follow-up due to geographical reasons; (9) Cognitive impairment or inability to provide written informed consent.

Design outcomes

Primary

Measure	Time frame
the rate of LSIL or worse lesions;	—

Secondary

Measure	Time frame
the rate of persistent HPV infection and the ratio of HSIL or worse;	—

Countries

China

Contacts

Public ContactLili Chen

Women's Hospital School of Medicine Zhejiang University

5197004@zju.edu.cn+86 139 5813 8597

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026