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NCT Number: NCT06491888

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

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.

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Key information

Conditions

Uterine Cervical Cancer Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female High Grade Squamous Intraepithelial Lesions Low Grade Squamous Intraepithelial Lesions Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Precancerous Conditions Squamous Intraepithelial Lesions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lei Li

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Detection of Cervical Lesions by Fluorescence Photoelectric Image

Diagnostic Test

Photoelectric detection was carried out on the subjects of the experimental group.

Primary outcomes

  1. Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.

    Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.

    Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings.

  2. Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector.

    Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.

    The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared between the fluorescence photoelectric technology and HPV detection results and cytology results, and the consistency and coincidence between the fluorescence photoelectric technology and HPV detection results and cytology results were calculated.

Secondary outcomes

  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.

    The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared with the results of HPV detection and cytology.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Li, M.D.

CONTACT

[email protected]

+8613911988831

Sponsors and collaborators

Lead sponsor

Lei Li

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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