Genetic Alterations and clinical record in surgically debulked OVarian cancer patients by Liquid biopsy And whole eXome analYsis

Not Applicable

Recruiting

• Conditions: ovarian cancer

• Registration Number: JPRN-UMIN000050754
• Lead Sponsor: ational Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-03
• Last Update Posted: 17 October 2023
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients with a history of treatment with PARP inhibitors or bevacizumab. 2.Patients who plan to use bevacizumab for preoperative adjuvant chemotherapy. 3.Persons with a history of malignancy(*6) (*6)Patients with a recurrence-free period of at least 5 years or with basal or spinous cell carcinoma of the skin, superficial bladder cancer, cervical cancer, carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma equivalent lesions that are considered cured by local treatment may be enrolled. 4.Persons with active local or systemic infections requiring treatment. 5.Persons who are HBs antigen positive, HBc antibody positive(*7) or HCV antibody positive(*8) (*7) HBc antibody positive, but HBV-DNA negative is acceptable for registration. (*8) HCV antibody-positive but HCV-RNA-negative patients are eligible for registration. 6.Must be HIV antibody positive (HIV antibodies may be untested for registration). 7.Patients with a history of interstitial lung disease requiring treatment (interstitial pneumonia, pulmonary fibrosis, etc.) or extensive findings of these diseases on CT. 8.Patients with uncontrolled complications(*8). (*8)Gastrointestinal bleeding, cardiac disease, glaucoma, diabetes, etc. 9.Patients receiving continuous systemic administration (oral or intravenous) of steroids (prednisolone equivalent of 10 mg/day or more for at least 2 weeks) 10.Persons who are judged to have difficulty enrolling in this study due to clinically problematic psychiatric disorders. 11.History of hemoptysis (sputum of 2.5 mL or more of fresh blood). 12.Pregnant or lactating women. 13.Other persons who are deemed by the physician in charge to be unsuitable for enrollment in this study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS), sensitivity and specificity of ctDNA for surgical completion, ctDNA positivity rate, ctDNA negativity rate, percentage of abnormal genes, and abnormal gene expression will be established and correlations of these outcomes with other clinicopathologic and molecular features and perioperative treatment will be analyzed in an exploratory manner.