Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03203993
Eligibility Criteria:
Inclusion Criteria:
* Be able and willing to sign the informed consent form (ICF)
* Female aged 18 years or over
* Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following:
* standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulkingand/or
* surgical resection and radiographic evidence consistent with Stage III or IV ovarian cancer
* biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer
* Have availability of paraffin-embedded archivedtumor tissue block (preferred) or,if a block is not possible, a minimum of twenty 5-μm unstained sections. (Tumor tissue should be archived at diagnosis. 10 slides is utilized for sBRCA testing after the enrolment. Another 10 slides is utilized for exploratory evaluation of HRR gene mutations in a retrospective way.)
* Have a diagnosis that is within 60 days of informed consent
Exclusion Criteria:
* Have a diagnosis of additional concurrent malignancies or previous diagnosis of another malignancy with current evidence of residual disease
* Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
* Be currently participating in any other clinical trial for first-line treatment of ovarian cancer
* Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT03203993
Study Brief:
Protocol Section:
NCT03203993