Epithelial Ovarian CancerPhase 2NCT04651946
Cell-free DNA Methylation for Epithelial Ovarian Cancer
A Phase 2 study testing DNA methylation testing in people with Epithelial Ovarian Cancer and DNA Methylation, run by Lei Li at 1 site in China.
Trial summary
Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, DNA Methylation, Benign Ovarian Tumor
- What is being tested?
- DNA methylation testing
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2020to 26 Nov 2022
- Phase
- Phase 2
- 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
Who may be able to join
- With definite histological diagnosis of epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set.
- With sufficient fresh peripheral serum and ovarian samples for DNA methylation testing before with or without after major surgeries.
- Aged 18 years or older.
- Signed an approved informed consents
Who cannot join
- Not meeting all of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 8613911988831, lileigh@163.com
About this study
Official title: Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer: The Training and Validation Sets in China
Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages.
In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues.
Read more
In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors.
In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.
- Conditions
- Epithelial Ovarian Cancer, DNA Methylation, Benign Ovarian Tumor, Training Set, Validation Set, Cell-free DNA
- Being tested
- DNA methylation testing
- 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.
DNA methylation testingDiagnostic test
Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut-off values of targeted DNA methylation in epithelial ovarian cancer
The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.
Measured: Two years
Secondary outcomes (1)
Accuracy of serum DNA methylation in epithelial ovarian cancer
The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value.
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 posted3 Dec 2020
- Study start26 Nov 2020
- Primary completion26 Nov 2022 (estimated)
- Study completion26 Nov 2022 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All eligible patients accept DNA methylation testing in serum and in ovarian tissues.
- Masking
- None (open label)
- Enrolment
- 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
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651946
- Sponsor's protocol ID
- EOC-METHY
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 3 Dec 2020
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer: The Training and Validation Sets in China
- ClinicalTrials.gov ID
- NCT04651946
- Acronym / sponsor ID
- EOC-METHY
- Conditions
- Epithelial Ovarian Cancer, DNA Methylation, Benign Ovarian Tumor, Training Set, Validation Set, Cell-free DNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 26 Nov 2022 (estimated)
- Study completion
- 26 Nov 2022 (estimated)
- First posted
- 3 Dec 2020 (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.
Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages.
In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues.
In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors.
In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- All eligible patients accept DNA methylation testing in serum and in ovarian tissues.
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With definite histological diagnosis of epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set.
- With sufficient fresh peripheral serum and ovarian samples for DNA methylation testing before with or without after major surgeries.
- Aged 18 years or older.
- Signed an approved informed consents
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria.
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 |
|---|---|---|
| DNA methylation testingMethylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum | Diagnostic test | – |
Primary outcome
Cut-off values of targeted DNA methylation in epithelial ovarian cancer
Time frame: Two years
The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.
1 secondary outcome
Accuracy of serum DNA methylation in epithelial ovarian cancer
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 3 Dec 2020.
Related trials for Epithelial Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DNA methylation testing in people with Epithelial Ovarian Cancer and DNA Methylation, 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 4 inclusion and 1 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 3 Dec 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cut-off values of targeted DNA methylation in epithelial ovarian cancer (time frame: Two years). 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 3 Dec 2020.