high grade serous ovarian cancer
Conditions
Sponsors
Ethics Committee of the First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subject understands the test procedure, signs informed consent, voluntarily participates in the study, and is capable of following this protocol; 2. Above the age of 18 (inclusive); 3. Initial treatment of patients with complete clinical data; 4. ECOG physiological status score 0-3, life expectancy > 6 months; 5. Preoperative CA125/CEA > 25 and both CA125 and HE4 increased, indicating that she was suspected to be a patient with ovarian, fallopian tube or primary peritoneal cancer, and was eventually pathologically confirmed as Stage II-IV high-grade serous ovarian cancer (FIGO 2014). 6. Can perform surgical resection and provide residual tumor tissue or formalin fixed and paraffin-embedded tumor tissue samples for MRD detection (free) and eccDNA analysis (free); 7. The subject agrees to collect blood samples for MRD and eccDNA testing; (Free of charge) 8. Good organ function, including: 1) Neutrophil count =1500/µL; 2) Platelet =100000/µL; 3) Hemoglobin =8g/dL; 4) Serum creatinine = 1.5 times the upper limit of normal, or creatinine clearance =60mL/min(calculated by Cockcroft-Gault formula) 5) Total bilirubin = 1.5 times the upper limit of normal value or direct bilirubin = 1.0 times the upper limit of normal value; 6) AST and ALT = 2.5 times of the upper limit of normal value. When there is liver metastasis, it must be less than 5 times the upper limit of normal value.
Exclusion criteria
Exclusion criteria: 1. People who are known to be allergic to platinum drugs (or active or inactive components of drugs with similar chemical structure); 2. Symptomatic and uncontrollable brain or meningeal metastasis; 3. Malignant tumors without ovarian cancer within 2 years before enrollment (except for fully treated basal cell or squamous cell skin cancer); 4. Serious or uncontrollable diseases, including but not limited to: uncontrollable nausea and vomiting, gastrointestinal diseases that cannot swallow or may interfere with drug absorption and metabolism; Active period of virus infection; Mental illness affecting patients to sign informed consent; Have a history of serious cardiovascular disease; 5. History of blood transfusion within 4 weeks before operation; 6. Patients who are pregnant or breastfeeding, or plan to become pregnant during study treatment; 7. The researcher believes that the subject is not suitable to participate in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CA125;HE4;image evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| CA19-9; | — |
Countries
China
Contacts
Public ContactZhou Ying
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed