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CIN2+detection ability of Uterine Cervical Endoscopy versus Colposcopy in Patients with suspected Uterine Cervical Cancer: A Multicenter, Open-label, Randomized Clinical Trial (Phase III) (UCE trial)

Phase III study of Uterine Cervical Endoscopy versus Colposcopy (UCE trial)

Kobara Hideki

Kagawa University Hospital

1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793

kobara.hideki@kagawa-u.ac.jp

Nishiyama Noriko

Kagawa University Hospital

1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793

+81-87-891-2156

nishiyama.noriko@kagawa-u.ac.jp

Recruiting

Mar. 19, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

diagnostic purpose

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

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

Female

Uterine cervical neoplasms

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.

uterine cervical neoplasm, uterine cervical cancer

Endoscopy, Magnifying endoscopy with narrow band imaging

C04

D004724

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).

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

+81-87-891-2011

Feb. 07, 2024

Yes

All information on research subjects, such as case reports, documents and correspondence, specimens, etc., shall be identified by a unique number (research subject identification code) newly assigned at the time of registration, with the name and medical record number deleted, and no information leading to the identification of specific individuals shall be used in this process. The principal investigator should prepare a list of the correspondence between the names of research subjects and the research subject identification code, and store it appropriately in a lockable place in the medical institution where the research is conducted. Any attempt to identify specific individuals with regard to research subject identification coded samples and information without reasonable grounds is prohibited. Regarding patient information coded for research subject identification, data management, analysis, etc. will be carried out on a PC installed in the gastroenterology department, which has strict security measures.

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