- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06420427
Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery
May 14, 2024 updated by: Sheng Xiujie, The Third Affiliated Hospital of Guangzhou Medical University
Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiujie Sheng, Prof
- Phone Number: 86-20-81292726
- Email: 2008691150@gzhmu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510150
- Recruiting
- The Third Affiliated Hospital of Guangzhou Medical University
-
Contact:
- Baixue Li, MD
- Phone Number: 86-02-81292726
- Email: 19902275248@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensitivity
Time Frame: 2 year
|
true positive rate
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xiujie Sheng, Prof, The Third Affiliated Hospital of Guangzhou Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
January 30, 2027
Study Registration Dates
First Submitted
May 14, 2024
First Submitted That Met QC Criteria
May 14, 2024
First Posted (Actual)
May 20, 2024
Study Record Updates
Last Update Posted (Actual)
May 20, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Disease Attributes
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Recurrence
Other Study ID Numbers
- CCA2024005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
publish an article
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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