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NCT06866392Not yet recruiting

Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection and Epigenetic Procotol

Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection Combined with Epigenetic Procotol

Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
4200 (estimated)
First submitted
4 Mar 2025
Start date
15 Mar 2025
Primary completion date
15 Mar 2027
Lead sponsor
Peking Union Medical College Hospital
NCT number
NCT06866392

What you commit to

  • Study type: Observational
  • Planned participants: 4200
  • From 15 Mar 2025 to the primary completion date, 15 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of cervical treatment (coning, ablation, or photodynamic therapy)
  • There are definite immunosuppression conditions, such as HIV infection or organ transplantation
  • Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)
  • A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites
  • The other conditions of this study were not considered appropriate by the researchers

Other

  • Cervical dysplasia (congenital malformation or double uterus, etc.)
  • The patient is in pregnancy or puerperium

Who the study is looking for

  • Women between the ages of 18 and 65 who have already had sex life
  • HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US
  • No history of cervical cancer and cervical physical therapy, a complete cervix
  • No menstrual period, no sexual activity and vaginal medication within 48 hours
  • The vagina or cervix is not in a stage of acute inflammation
  • Willing to participate in the study with full informed consent

Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.