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Not yet recruiting NCT06866392

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

— Observational Cervical Cancer Cervical Intraepithelial Neoplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: photoelectric detection.
Who it may be relevant to
Registry conditions: Cervical Cancer, Cervical Intraepithelial Neoplasia. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test photoelectric detection
    Methylation test and 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 and colposcopic biopsy and OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results.

Primary outcome measures

  • Sensitivity and specificity of a photoelectric image detector for cervical lesions [Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy]
Secondary outcome measures (1)
  • Detection rate of CIN2+ by photoelectric cervical lesion image detector [Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Cervical dysplasia (congenital malformation or double uterus, etc.)
  • 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 patient is in pregnancy or puerperium
  • The other conditions of this study were not considered appropriate by the researchers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06866392 · CCAZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗