Epithelial Ovarian CancerNCT05801276
ctDNA Methylation for Detecting Ovarian Cancer
An observational study of Epithelial Ovarian Cancer and Circulating Tumor DNA, run by Lei Li at 1 site in China.
Trial summary
Ovarian cancer is one of the most dangerous and leading gynecological cancer, with significant cancer-related mortality among women. However, current detection methods are still limited, with approximately 70% of patients with high-grade serous ovarian cancer often being advanced at the initial diagnosis and more than… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Circulating Tumor DNA, DNA Methylation
- What is being tested?
- Methylation assay
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2023to 24 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients ready for surgical treatment for pelvic mass or adnexal mass. The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, M.D., 8613911988831, lileigh@163.com
About this study
Official title: Exploration of Plasma CDO1 and HOXA9 DNA Methylation for Detecting Epithelial Ovarian Cancer: A Clinical Trial in China
Ovarian cancer is one of the most dangerous and leading gynecological cancer, with significant cancer-related mortality among women. However, current detection methods are still limited, with approximately 70% of patients with high-grade serous ovarian cancer often being advanced at the initial diagnosis and more than 80% with intraperitoneal spread. The five-year survival rate for late detection is only 29%; on the contrary, if detected early, the five-year survival rate can reach 92%. Therefore, early diagnosis and detection are essential in diagnosing and treating ovarian cancer. Liquid biopsy has attracted widespread attention because of its non-invasive, real-time, and dynamic characteristics. Cell-free DNA in plasma can identify a small tumor burden well and reflect the clinical cancer information of cells.The role of hypermethylation in developing malignant tumors has received increasing attention. Methylation is one of epigenetics and plays a vital role in the occurrence and development of tumors. According to previous research basis of the researchers, it has been found that CDO1 and HOXA9 genes show hypermethylation in ovarian cancer, and they are considered one of the biomarkers for detection. Therefore, this study will further explore the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and compared with ovarian pathology results; the application of methylation detection technology in ovarian cancer/precancerous lesions will further explore the application value of non-invasive diagnosis and prognostic follow-up.This study will involve three centers and is expected to enroll more than 1,400 clinical subjects, further examine the consistency of methylation detection kits with the histopathological examination, ROMA index, and Sanger sequencing results, and obtain sensitivity and specificity technical performance parameters.
Read the 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.
- Conditions
- Epithelial Ovarian Cancer, Circulating Tumor DNA, DNA Methylation, Non-invasive Diagnosis, CA125, Human Epididymis Protein 4
- Being tested
- Methylation assay
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylation assayDiagnostic test
Methylation assay of CDO1 and HOXA9 genes in plasma circulating tumor DNA
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity
Diagnostic sensitivity of methylation assay for detecting epithelial ovarian cancer
Measured: One month
Diagnostic specificity
Diagnostic specificity of methylation assay for detecting epithelial ovarian cancer
Measured: One month
Secondary outcomes (1)
Progression-free survival
Progression-free survival after the last treatment for cancer
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start24 Mar 2023
- Primary completion24 Mar 2024 (estimated)
- Study completion24 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801276
- Sponsor's protocol ID
- EOC-METHY2
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Plasma CDO1 and HOXA9 DNA Methylation for Detecting Epithelial Ovarian Cancer: A Clinical Trial in China
- ClinicalTrials.gov ID
- NCT05801276
- Acronym / sponsor ID
- EOC-METHY2
- Conditions
- Epithelial Ovarian Cancer, Circulating Tumor DNA, DNA Methylation, Non-invasive Diagnosis, CA125, Human Epididymis Protein 4
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 24 Mar 2024 (estimated)
- Study completion
- 24 Mar 2026 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ovarian cancer is one of the most dangerous and leading gynecological cancer, with significant cancer-related mortality among women. However, current detection methods are still limited, with approximately 70% of patients with high-grade serous ovarian cancer often being advanced at the initial diagnosis and more than 80% with intraperitoneal spread. The five-year survival rate for late detection is only 29%; on the contrary, if detected early, the five-year survival rate can reach 92%. Therefore, early diagnosis and detection are essential in diagnosing and treating ovarian cancer. Liquid biopsy has attracted widespread attention because of its non-invasive, real-time, and dynamic characteristics. Cell-free DNA in plasma can identify a small tumor burden well and reflect the clinical cancer information of cells.The role of hypermethylation in developing malignant tumors has received increasing attention. Methylation is one of epigenetics and plays a vital role in the occurrence and development of tumors. According to previous research basis of the researchers, it has been found that CDO1 and HOXA9 genes show hypermethylation in ovarian cancer, and they are considered one of the biomarkers for detection. Therefore, this study will further explore the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and compared with ovarian pathology results; the application of methylation detection technology in ovarian cancer/precancerous lesions will further explore the application value of non-invasive diagnosis and prognostic follow-up.This study will involve three centers and is expected to enroll more than 1,400 clinical subjects, further examine the consistency of methylation detection kits with the histopathological examination, ROMA index, and Sanger sequencing results, and obtain sensitivity and specificity technical performance parameters.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ready for surgical treatment for pelvic mass or adnexal mass. The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylation assayMethylation assay of CDO1 and HOXA9 genes in plasma circulating tumor DNA | Diagnostic test | – |
Primary outcome
Diagnostic sensitivity
Time frame: One month
Diagnostic sensitivity of methylation assay for detecting epithelial ovarian cancer
Diagnostic specificity
Time frame: One month
Diagnostic specificity of methylation assay for detecting epithelial ovarian cancer
1 secondary outcome
Progression-free survival
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer and Circulating Tumor DNA, run by Lei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.