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Phase III study of Uterine Cervical Endoscopy versus Colposcopy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Uterine cervical neoplasms
Date of first enrollment	27/03/2025
Target sample size	310
Countries of recruitment
Study type	Interventional
Intervention(s)	Group A: Uterine Cervical Endoscopy (UCE) Group B: Standard Colposcopy Both groups have a screening period of 4 weeks, a period of 1 day to undergo the examination and a post-examination observation period of approximately one year. However, the gynecologist will always follow up with colposcopy within the period from the day of examination to the 84th day after the examination (date and time to be determined by the physician) to ensure that participants assigned to Group A do not lead to the delayed detection of neoplasms that could have been detected by colposcopy.

Outcome(s)

Primary Outcome

Sensitivity to detect CIN2+ in each biopsy tissue of UCE and colposcopy in each case Definition of CIN2+ includes CIN2, CIN3, AIS(Adenocarcinoma in situ), ICC(Invasive cervical cancer).

Secondary Outcome

1. (Major secondary endpoint) Acceptance by the examinee: evaluated by the Visual Analogue Scale (VAS) score (0-10 cm), a pain score for the examination using a questionnaire. 2. sensitivity and specificity of CIN1+ in both groups by case or lesion 3. sensitivity and specificity of CIN2+ based on histopathological stage in both groups in of cases or lesion units 4. false negative rate of CIN2+ in the UCE group*. *False negative is defined as the detection of CIN2+ that was not noted on the initial test in each group on a case-by-case basis. 5. examinee acceptability to the patient: discomfort, embarrassment, biopsy-related pain, as assessed by VAS score. 6. examinee acceptability: comparison of pain between the two subject groups with and without biopsy, evaluated by VAS score 7. examinee acceptability: percentage of both groups for the next desired test, assessed by VAS score 8. percentage of successful circumferential cervical observation in both groups Examine the performance of each test method itself as it relates to securing the field of view of the cervix. 9. comparison of total number of biopsies performed by UCE and colposcopy in both groups 10. evaluation of the eligibility of endoscopic and punch biopsy specimens obtained in each of the two groups and the validity of the pathological diagnosis (I) Depth diameter of the subepithelial stroma of the biopsy specimen (distance from the upper margin of the stroma to the deepest stroma) (II) Evaluation of subepithelial stromal tissue (presence or absence of subepithelial stromal tissue and presence or absence of stromal invasion) (III) Pathology diagnostic compliance rate for intraepithelial tumors and subepithelial invasive carcinomas. All biopsy specimens will be collected at one location, blinded as to which group they belong to, and a central batch decision will be made by a total of three pathologists, one specializing in gynecologic tumor pathology and two specializing in tumor pathology. One gynecologic oncologist with expertise in colposcopic diagnosis and biopsy will be involved in the audit from a clinical standpoint. Microimages are always stored in case additional analysis is required. 11. examination time (endoscope insertion to removal vs. cusco insertion to removal) 12. percentage of endocervical balloon use in the UCE group 13. Safety endpoints Percentage of adverse events (Grade 2 or higher): bleeding (difficulty in stopping bleeding), Post-biopsy bleeding requiring hemostatic treatment (gauze compression, electrocoagulation, etc.), Tissue inflammation due to acetic acid requiring treatment, Peritonitis due to bacterial infection, Abdominal pain (pain inability to stand up), Gas embolization, Intra-abdominal seeding, Respiratory distress, Shock, Death, Failure of equipment

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Female
Include criteria	1) Patients with a positive Pap smear test result of ASC-US, ASC-H, LSIL, or HSIL If there are multiple candidates on the same day due to the limited number of tests possible per day, HSIL and ASC-H will be given priority for entry. 2) Patients who are age between 18 and 64 years 3) Patients with provision of written informed consent
Exclude criteria	1) Patients who have already undergone colposcopic examination for the current cytological abnormality 2) Patients who already have a confirmed diagnosis of CIN or carcinoma for the current cytological abnormality 3) Those who are postmenopausal. 4) Patients taking antithrombotic drugs or with a blood disorder for which a biopsy is contraindicated 5) Patients with mental illness and judged inappropriate for study participation by the attending physician 6) Patients who are pregnant or possibly pregnant 7) Patients with a history of uterine cervical operation