## Protocol Section
### Identification Module
**NCT ID:** NCT05851079

**Brief Title:** Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions

**Official Title:** Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions

#### Organization Study ID Info
**ID:** IRB-20210333-R
#### Organization
**Class:** OTHER
**Full Name:** Women's Hospital School Of Medicine Zhejiang University
### Status Module
#### Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-09

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-05

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12-10

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2023-05-09
**Type:** ACTUAL
**Study First Submit Date:** 2023-04-24
**Study First Submit QC Date:** 2023-05-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Wuhan Central Hospital

**Class:** OTHER

**Name:** Tongji Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Women's Hospital School Of Medicine Zhejiang University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this observational study is to compare the accuracy and sensitivity of High-throughput human papilloma virus(HPV) typing and integrated assays with routine screening protocols (Cobas HPV test combined with thinprep cytologic test(TCT) for the detection of cervical intraepithelial neoplasia in the general and hospital populations.

The main questions it aims to answer are:

* High-throughput HPV typing and integrated assays can screen for ≥ cervical intraepithelial neoplasia (CIN2 or CIN3) with high sensitivity and accuracy.
* High-throughput HPV typing and integrated assays can be promoted as a screening tool for cervical cancer.

Participants will be screened with routine screening protocols (Cobas HPV test combined with TCT test), and if the results are abnormal, colposcopy and cervical biopsy will be performed.

**Detailed Description:** 1. Stratified experimental design:

   Relying on the project's clinical multicenter to recruit patients for routine HPV screening in hospital outpatient clinics, for HPV high-risk type-positive subjects. The subjects with positive HPV types will continue to undergo TCT and colposcopic biopsy, and the remaining specimens after routine screening will be collected for high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.
2. Parallel experimental design:

   A multicenter cohort of 12,000 permanent residents was recruited for routine cervical cancer screening(HPV+TCT combined screening), and the remaining specimens were collected after the conventional screening to test the indexes of high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.
3. Prospective cohort study design:

Based on a multicenter cohort of cervical cancer screening based on the project group, 3000 cervical cancer patients with HPV-positive routine screening and colposcopic biopsies were enrolled. The cohort was followed up regularly for 3 years with routine HPV+TCT and colposcopy, and cervical biopsy if necessary. And specimens remaining after routine screening will be collected for testing of high-throughput HPV typing and integrated assays.

4.subject selection:

1. .Stratified study design subjects were selected from patients who were first screened for cervical cancer in hospital outpatient clinics.
2. .Parallel trial design subjects were selected from resident female residents in a cohort of cervical cancer screening established by a clinical center.
3. .The prospective cohort study was designed to include HPV-positive patients in the cohort of cervical cancer screening established by the clinical center and whose cervical lesions were excluded by colposcopic biopsy.

5.This project is a multicenter prospective cohort study to investigate the immediate, 1st year, 2nd year and 3rd year cumulative risk of developing CIN2+ and CIN3+ in HPV 16 or 18-positive patients with positive and negative test results by integrating test results through a logistic Weibull model to assess whether colposcopy can be delayed and thus serve as a cervical cancer screening triage by comparing with risk values and clinical thresholds in the 2019 American Society for Colposcopy and Cervical Pathology(ASCCP)guidelines.

### Conditions Module

**Conditions:**

- Cervical Intraepithelial Neoplasia Grade 2/3

- Cervical Lesion

**Keywords:**

- Screening methods

- Cervical Lesion

- Sensitivity

- Accuracy

### Design Module

#### Bio Spec

**Description:** Cervical exfoliated cells；Cervical biopsy

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 15000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Relying on the project's clinical multicenter to recruit patients for routine HPV screening in hospital outpatient clinics, for HPV high-risk type-positive subjects. The subjects with positive HPV types will continue to undergo TCT and colposcopic biopsy, and the remaining specimens after routine screening will be collected for high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.

**Intervention Names:**

- Diagnostic Test: TCT test

- Diagnostic Test: Vaginoscopy

- Diagnostic Test: High throughput HPV typing and integration detection methods

- Diagnostic Test: Cobas HPV test

**Label:** 1. Stratified experimental design

#### Arm Group 2

**Description:** A multicenter cohort of 12,000 permanent residents was recruited for routine cervical cancer screening(HPV+TCT combined screening), and the remaining specimens were collected after the conventional screening to test the indexes of high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.

**Intervention Names:**

- Diagnostic Test: TCT test

- Diagnostic Test: High throughput HPV typing and integration detection methods

- Diagnostic Test: Cobas HPV test

**Label:** 2. Parallel experimental design

#### Arm Group 3

**Description:** Based on a multicenter cohort of cervical cancer screening based on the project group, 3000 cervical cancer patients with HPV-positive routine screening and colposcopic biopsies were enrolled. The cohort was followed up regularly for 3 years with routine HPV+TCT and colposcopy, and cervical biopsy if necessary. And specimens remaining after routine screening will be collected for testing of high-throughput HPV typing and integrated assays.

**Intervention Names:**

- Diagnostic Test: TCT test

- Diagnostic Test: Vaginoscopy

- Diagnostic Test: High throughput HPV typing and integration detection methods

- Diagnostic Test: Cobas HPV test

**Label:** 3. Prospective cohort study design:

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1. Stratified experimental design

- 2. Parallel experimental design

- 3. Prospective cohort study design:

**Description:** These tests were performed on cervical exfoliated cells.

**Name:** TCT test

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- 1. Stratified experimental design

- 3. Prospective cohort study design:

**Description:** To obtain the results of the patient's pathology report.

**Name:** Vaginoscopy

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- 1. Stratified experimental design

- 2. Parallel experimental design

- 3. Prospective cohort study design:

**Description:** This is screening for ≥ cervical intraepithelial tumors (CIN2 or CIN3).

**Name:** High throughput HPV typing and integration detection methods

**Type:** DIAGNOSTIC_TEST

#### Intervention 4

**Arm Group Labels:**

- 1. Stratified experimental design

- 2. Parallel experimental design

- 3. Prospective cohort study design:

**Description:** To obtain HPV typing results.

**Name:** Cobas HPV test

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Patients who meet the requirements for referral colposcopy were further examined for CIN2+ by pathology.

**Measure:** the risk of cervical intraepithelial neoplasia(CIN) 2 or worse

**Time Frame:** 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. First screening.
2. History of sexual intercourse.

Exclusion Criteria:

1. Previous CIN, cervical cancer or other cervical lesions;
2. History of cervical treatment;
3. Age \<25, \>70 years;
4. Pregnancy.

**Gender Based:** True

**Gender Description:** Female

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 25 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects were recruited in the general and hospital populations.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wang71hui@zju.deu.cn

**Name:** Hui Wang, PhD

**Phone:** 0571-89998857

**Role:** CONTACT

**Contact 2:**

**Email:** 5198009@zju.edu.cn

**Name:** Xiao Li, PhD

**Phone:** 13958160137

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** wang71hui@zju.deu.cn

- **Name:** Hui Wang, PhD

- **Phone:** 057189998857

- **Role:** CONTACT

**Country:** China

**Facility:** Women's hospital school of medicine zhejiang university

**State:** Zhejiang

**Status:** RECRUITING

**Zip:** 310000

#### Overall Officials

**Official 1:**

**Affiliation:** Women's Hospital School Of Medicine Zhejiang University

**Name:** Hui Wang, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000011230

- Term: Precancerous Conditions

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M5826

- Name: Uterine Cervical Dysplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: HIGH

- As Found: Cervical Lesions

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T1074

- Name: Cervical Intraepithelial Neoplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

### Condition Browse Module - Meshes

- ID: D000002578

- Term: Uterine Cervical Dysplasia

- ID: D000002577

- Term: Uterine Cervical Diseases

### Misc Info Module

- Version Holder: 2024-05-24
