NCT05931055Not yet recruiting
The Effectiveness of Liquid Biopsy in Differential Diagnosis and Early Screening of Epithelial Ovarian Cancer
The Effectiveness of Liquid Biopsy in Differential Diagnosis of Benign and Malignant Ovarian Tumors and Early Screening of Epithelial Ovarian Cancer, and the Exploration of Invasive Mechanisms of Epithelial Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 5 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
At present, there is a lack of effective screening methods. It is urgent to explore new non-invasive detection methods for early diagnosis of epithelial ovarian cancer and non-invasive differentiation methods for benign and malignant ovarian tumors. Liquid biopsy technology has great potential for early screening of tumors. The fragmentation patterns of cfDNA fragments in plasma and the uneven coverage of the genome can indirectly reflect the state of gene expression regulation in vivo. Its characteristics mainly include copy number variation (CNV), Nucleosome footprint, fragment length and motif. The number of proteins in a proteome can sometimes exceed the number of genomes. It includes "structural Proteomics" and "functional Proteomics". At present, research has explored the use of urinary protein biomarkers for early diagnosis of gastric cancer. "Deep Visual Proteomics (DVP)" reveals the mechanism driving tumor evolution and new therapeutic targets for tumors. Using the currently mature low depth WGS sequencing technology, this study aims to explore its clinical application in the differentiation and early screening of epithelial ovarian cancer, as well as monitoring the course of epithelial ovarian cancer, including the detection of minimal residual lesions (MRD) and monitoring of recurrence (MOR). This study also explores the role of urine proteomics in the differentiation of benign and malignant ovarian tumors, early screening and invasiveness of epithelial ovarian cancer, and monitoring the course of epithelial ovarian cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 12 Jun 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT05931055
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jan 2024 to the primary completion date, 1 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received chemotherapy or pelvic radiation therapy within 6 months prior to sample collection;
- Researchers have confirmed patients with recurrent ovarian cancer, or ovarian cancer patients who have received chemotherapy and/or surgical treatment;
- Contraindications for surgical evaluation and inability to obtain ovarian pathology or surgical pathological information;
Other illness
- Patients with confirmed ovarian cancer who have undergone surgery and obtained histopathology;
Other
- Samples that do not meet the requirements for collecting and storing assessment reagent samples; Or contaminated or suspected contaminated samples;
- Samples with missing, incomplete, and untraceable clinical information of corresponding patients;
- Pregnant and lactating women;
- Patients who cannot cooperate with examinations, have poor compliance, and cannot follow up regularly.
Who the study is looking for
- Age ≥ 18 years old, female;
- Suspicious or considering mass in the accessory area, requiring surgical treatment and obtaining pathology of ovarian tissue;
- Having pelvic imaging evaluation results, including ultrasound, MRI, CT, or PET/CT;
- Serum CA125 and HE4 tests are tested before surgery, and ROMA evaluation results is obtained;
- Volunteer to participate in this research and sign an informed consent form; (6) Good compliance and regular follow-up.
Age in the registry: 18 years to - · Sex: Female
This page is information, not medical advice. Discuss any trial with your doctor.