- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05801276
ctDNA Methylation for Detecting Ovarian Cancer
Exploration of Plasma CDO1 and HOXA9 DNA Methylation for Detecting Epithelial Ovarian Cancer: A Clinical Trial in China
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study has two phases: the "Clinical Performance Validation" cohort and the "Assay Accuracy Verification" cohort.
The " Clinical Performance Validation" phase of this study will assess the reagents to detect plasma samples; patients undergo routine examinations by clinical trial institutions, including but not limited to tumor markers and histopathological examinations. The clinical performance of the assessment reagents was systematically evaluated by evaluating the consistency between the test results of the assessment reagents and the histopathological examination results, as well as the surface of the ROMA index and the histopathological examination results.
During the "Assay Accuracy Verification" phase of this study, a part of the qualified samples was randomly selected. The Sanger sequencing method was used as a comparison method to evaluate the detection accuracy of the test reagents for detecting the methylation of CDO1 and HOXA9 genes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Lei Li
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients ready for surgical treatment for pelvic mass or adnexal mass
- Age is greater than or equal to 18 years
- Not receiving any chemotherapy, physical therapy, or surgical treatment for ovarian lesions
- With ovarian pathology
- Willing to be tested and signed an informed consent form
- With available data of plasma CA125, Human epididymis protein 4 and effective imaging results
- The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas
Exclusion Criteria:
- Not meeting all the including criteria
- A sample of patients withdrawing from the trial
- Samples that the investigator believes should be excluded from this trial
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic sensitivity
Time Frame: One month
|
Diagnostic sensitivity of methylation assay for detecting epithelial ovarian cancer
|
One month
|
Diagnostic specificity
Time Frame: One month
|
Diagnostic specificity of methylation assay for detecting epithelial ovarian cancer
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: Two years
|
Progression-free survival after the last treatment for cancer
|
Two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- EOC-METHY2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Epithelial Ovarian Cancer
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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