## Protocol Section
### Identification Module
**NCT ID:** NCT06420427

**Brief Title:** Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery

**Official Title:** Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment

#### Organization Study ID Info
**ID:** CCA2024005
#### Organization
**Class:** OTHER
**Full Name:** The Third Affiliated Hospital of Guangzhou Medical University
### Status Module
#### Completion Date
**Date:** 2027-01-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Third Affiliated Hospital of Guangzhou Medical University

#### Responsible Party

**Investigator Affiliation:** The Third Affiliated Hospital of Guangzhou Medical University

**Investigator Full Name:** Sheng Xiujie

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.

### Conditions Module

**Conditions:**

- cfHPV DNA in Plasma of Cervical Cancer Patients

**Keywords:**

- cfHPV DNA

- cervical cancer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Evaluation of recurrence risk and medication efficacy through liquid biopsy

**Name:** Assess the risk of recurrence and the efficacy of medication

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** true positive rate

**Measure:** sensitivity

**Time Frame:** 2 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
* Patients must be older than 18 years of age.
* Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy.
* Estimated life expectancy of more than three months.
* Understands the study protocol and voluntarily participates in the research by signing the informed consent form.
* Able to provide specimens and corresponding clinical information at each time point.

Exclusion Criteria:

* Patients who are participating in other clinical trials.
* Pregnant or breastfeeding women.
* Patients with severe mental illness.
* Patients who voluntarily withdraw.
* Patients unable to complete the study protocol.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 2008691150@gzhmu.edu.cn

**Name:** Xiujie Sheng, Prof

**Phone:** 86-20-81292726

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** 19902275248@163.com

- **Name:** Baixue Li, MD

- **Phone:** 86-02-81292726

- **Role:** CONTACT

**Country:** China

**Facility:** The Third Affiliated Hospital of Guangzhou Medical University

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510150

#### Overall Officials

**Official 1:**

**Affiliation:** The Third Affiliated Hospital of Guangzhou Medical University

**Name:** Xiujie Sheng, Prof

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** publish an article

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- 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

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

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

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrence

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- 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: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002583

- Term: Uterine Cervical Neoplasms

- ID: D000012008

- Term: Recurrence

### Misc Info Module

- Version Holder: 2024-05-31
