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Clinical study on screening and identification of tumor derived eccDNA for predicting HRD status of high-grade serous ovarian cancer (DAISY2)

Clinical study on screening and identification of tumor derived eccDNA for predicting HRD status of high-grade serous ovarian cancer (daisy2) - DAISY2

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066898
Enrollment
Unknown
Registered
2022-12-21
Start date
2022-12-25
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high grade serous ovarian cancer

Interventions

Sponsors

the First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

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 HRD test (free) and eccDNA analysis (free); 7. Subject agrees to collect blood sample for detection of HRR related gene mutation (free) eccDNA analysis (free); 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

MeasureTime frame
CA125;HE4;CA19-9;image evaluation;

Countries

China

Contacts

Public ContactZhou Ying

The First Affiliated Hospital of University of Science and Technology of China

caddiezy@ustc.edu.cn+86 13865901025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026