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 is the 2nd largest by 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 1,400 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.
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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 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.
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.
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.
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.
Methylation assay of CDO1 and HOXA9 genes in plasma circulating tumor DNA
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