An observational study in Epithelial Ovarian Cancer, Circulating Tumor DNA and DNA Methylation, sponsored by Lei Li. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Lei Li · Observational
Among 13 studies in Carcinoma, Ovarian Epithelial by Lei Li — 3 open to participants now, 3 under way, none of them phase 3. Carcinoma, Ovarian Epithelial · Lei Li.
Among the 13 studies in Carcinoma, Ovarian Epithelial by Lei Li, this one has the largest planned enrollment of the 10 observational ones that give a count, is one of 2 that started in 2023, is one of 10 observational ones, and was the 12th registered.
797 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 101 are open to participants now.
Browse Carcinoma, Ovarian Epithelial studies →3 of the 13 studies in Carcinoma, Ovarian Epithelial by Lei Li are open now, in 1 country. Recruiting first, the newest first:
Lei Li · Sites in China
Lei Li · Sites in China
By country, each count listing its studies:
Of the 75 Carcinoma, Ovarian Epithelial studies recruiting now, 50 (67%) set no upper age limit and 12 (16%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2023.
This study's planned enrollment of 5,000 is above the median of 200 across 91 observational studies indexed under Carcinoma, Ovarian Epithelial.
Median enrollment 400 across the 3 interventional studies, 350 across the 10 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Lei Li is the lead sponsor of 62 studies on the registry; 10 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Carcinoma, Ovarian Epithelial by Lei Li, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Ovarian cancer is one of the most dangerous and predominant gynecological cancers, with a high cancer-related mortality rate in women. However, current testing methods are still limited, and if detected early, patients have a five-year survival rate of 92%. Therefore, early diagnosis and detection are crucial for diagnosing and treating ovarian cancer. According to the results of the researchers' previous research, it has been found that CDO1 and HOXA9 genes are hypermethylated in ovarian cancer, and the expression of free DNA methylation in plasma can be used as one of the biomarkers for detection. In a single-center retrospective/prospective study, it has been demonstrated that the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and comparison with ovarian pathology results can achieve >80% sensitivity and specificity. To further explore the application of methylation detection technology in ovarian cancer, the application value of non-invasive diagnosis and prognosis follow-up will be explored to clarify the clinical application value of DNA methylation for early detection of ovarian cancer in the real world. The investigators will conduct a prospective multi-center cohort study, referred to as the OVAMethy study, which will involve more than ten research centers and is expected to recruit more than 5,000 clinical subjects to test the methylation detection kit and histopathology further, ROMA index and imaging results, and sensitivity and specificity technical performance parameters.
In this study, cell-free DNA will be extracted from the blood of outpatient opportunistic screening subjects, the methylation status of genes will be measured, and the test results will be obtained. Histological sampling was performed by current clinical practice in patients with clinical manifestations and corresponding examinations (e.g., abnormal uterine bleeding, ovarian mass/cyst on ultrasound, elevated tumor markers) suggesting ovarian lesions. Accuracy of screening for ovarian cancer based on histopathological analysis of blood ctDNA methylation. A 12-month clinical follow-up of women with DNA methylation at risk for ovarian cancer, including symptom analysis, physical examination, imaging studies (ultrasound, CT, or MRI), surgery or (biopsy) pathology, and tumors such as ROMA Marker determination. Collect 5ml of blood for methylation testing before treatment. For the hospital for treatment follow-up, the scheme for collecting patient information includes basic data (birthday, medical record number, height, weight, etc.), symptom analysis, physical examination, imaging examination (ultrasound, CT or MRI), surgery or (biopsy) pathology, Determination of tumor markers such as ROMA, as well as the use of main therapeutic drugs and courses of treatment, time to recurrence, re-treatment plan and course of treatment, time of death (such as those who died during the study), etc. Blood was collected for methylation detection. The 5ml blood collection points were (1). Before treatment (surgery/chemoradiotherapy/immunotherapy); (2). Follow-up visit one month after treatment; (3). Follow-up 3rd and 6th after treatment, 9, and 12 months, and complete follow-up cases and specimen collection before March 24, 2024.
Patient with pelvic mass or adnexal mass ready for surgical exploration
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CDO1 and HOXA9 methylation assay in plasma circulating tumor cells
Diagnostic sensitivity
Diagnostic sensitivity of methylation assay for detecting epithelial ovarian cancer
Time frame: One month
Diagnostic specificity
Diagnostic specificity of methylation assay for detecting epithelial ovarian cancer
Time frame: One month
Progression-free survival
Progression-free survival after the last treatment for cancer
Time frame: Two years
Started Mar 2023 (actual). Primary completion is estimated for Mar 2024, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Carcinoma, Ovarian Epithelial →
Lei Li