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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT03420118
Eligibility Criteria:
Pre-Screening Eligibility:
Inclusion Criteria:
* Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological cancers) and confirmed to be undergoing upfront debulking surgery/radiation
* Patient must be ≥16 years of age at the time of consent.
* Ability to understand and provide written informed consent.
* ECOG Performance Status ≤ 2.
* Patient must consent to provide tissue sample from surgery and blood samples
* Life expectancy ≥3 months.
Exclusion Criteria:
* Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease)
Eligibility for Patients with Gynecological Diagnosis
Inclusion Criteria:
* Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary peritoneal, uterine, cervical, vulvar and vaginal cancer and rare gynecological cancers).
* Patient must be ≥16 years of age at the time of consent.
* Ability to understand and provide written informed consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* Patient must consent to providing archival tissue and/or to undergo tumour biopsy and/or to provide blood or fluid collection samples. Patients will also be asked to provide a blood sample for germline mutation analysis.
* Life expectancy ≥3 months.
* No limits of previous lines of treatment.
Exclusion Criteria:
* Any contraindication to tumour biopsy or blood collection
* Patient with diagnosis of High grade serous Ovarian Cancer are excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03420118
Study Brief:
Protocol Section:
NCT03420118