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Not yet recruiting NCT06491888

A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening

No phase Interventional Uterine Cervical Cancer Cervical Intraepithelial Neoplasia High Grade Squamous Intraepithelial Lesions Low Grade Squamous Intraepithelial Lesions

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: Detection of Cervical Lesions by Fluorescence Photoelectric Image.
Who it may be relevant to
Registry conditions: Uterine Cervical Cancer, Cervical Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions. 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening

Overview

The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study. The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining. In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.

Interventions

  • Diagnostic test Detection of Cervical Lesions by Fluorescence Photoelectric Image
    Photoelectric detection was carried out on the subjects of the experimental group.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 1\. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
  • 2\. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
  • 3\. Fully informed and agreed to participate in the study.
  • 4\. No history of cervical cancer disease and cancer in other parts.

Exclusion criteria

  • 1\. Cannot meet all Inclusion Criteria.
  • 2\. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
  • 3\. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • Lei Li — Beijing

Identifiers

NCT: NCT06491888 · OITS2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗