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

NCT06420427 | Recruiting

• 1 other identifier: CCA2024005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

cfHPV DNA in Plasma of Cervical Cancer Patients

Keywords

cfHPV DNA; cervical cancer

Outcome Measures

Primary Outcomes (1)

• sensitivity

  true positive rate

  2 year

Interventions

Assess the risk of recurrence and the efficacy of medication DIAGNOSTIC_TEST

Evaluation of recurrence risk and medication efficacy through liquid biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Xiujie Sheng, Prof

  The Third Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Xiujie Sheng, Prof

CONTACT

86-20-81292726; 2008691150@gzhmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)