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

NCT ID: NCT06420427

Last Updated: 2024-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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cfHPV DNA in Plasma of Cervical Cancer Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Assess the risk of recurrence and the efficacy of medication

Evaluation of recurrence risk and medication efficacy through liquid biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Third Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Sheng Xiujie

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiujie Sheng, Prof

Role: STUDY_CHAIR

The Third Affiliated Hospital of Guangzhou Medical University

Locations

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The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiujie Sheng, Prof

Role: CONTACT

86-20-81292726

Facility Contacts

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Baixue Li, MD

Role: primary

86-02-81292726

Other Identifiers

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CCA2024005

Identifier Type: -

Identifier Source: org_study_id

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