Uterine cervical neoplasms uterine cervical neoplasm, uterine cervical cancer
Conditions
Interventions
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 p
Endoscopy, Magnifying endoscopy with narrow band imaging
Sponsors
Kobara Hideki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 gynecolo | — |
Contacts
Public ContactNoriko Nishiyama
Kagawa University Hospital
Outcome results
None listed