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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT05963334
Eligibility Criteria:
Inclusion Criteria:
* Age above 18 years
* Cancer stage according to the International Federation of Gynecology and Obstetrics (FIGO) classification subdivided into the following categories; (I A, B, and C), II (A and B) III (A, B and C) and (IVA and B). Stage I: (tumor limited to the uterus (confined to the organ of origin) and subdivided into IA: below 5cm, IB : above 5 cm.
Stage II: Tumor extends beyond the uterus within the pelvis (invasion of surrounding organs) subdivided into IIA: adnexal involvement, IIB: involvement of other pelvic tissue.
Stage III: Tumor invades abdominal tissue (spread to nodes or tissue within the pelvis), subdivided into: IIIA: one site; IIIB: more than one site; IIIC: metastasis to the pelvic and/or para-aortic lymph node.
Stage IV: Tumor invades external organs to the uterus subdivided into IVA: tumor invading the bladder and/or rectum while IVB: distant metastasis(es).
-Indication for chemotherapy and life expectancy of at least 3 months Performance status is above and equal to 3 according to the Eastern Cooperative Oncology Group (ECOG).
Exclusion Criteria:
* Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
* Neutrophils (ANC) \< 2000 x mm3, platelets (PLT) \< 100,000 x mm3
* Inadequate renal function {creatinine (SCr) ≥1.5 x normal values} or liver function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x normal values).
Discontinuation criteria:
* Present or suspected hemorrhagic syndromes
* Inability to comply with protocol and follow-up
* Inability to access the study site for clinical visits
* Refusal of informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05963334
Study Brief:
Protocol Section:
NCT05963334