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:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT02285192
Eligibility Criteria:
Inclusion Criteria:
* The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:
* Uterine serous carcinoma
* Clear cell endometrial carcinoma
* Grade 3 endometrioid carcinoma
* Endometrial carcinosarcoma
* Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 \> 35 U/ml.
* Age ≥18 years
* Hemoglobin ≥10 g/dL
* Plasma albumin ≥3 g/dL
* GOG performance status ≤2
* Plasma glucose ≤200 mg/dL
* Plasma creatinine ≤1.6
* Well-controlled hypertension
* Medical clearance for surgery and considered an appropriate surgical candidate
* Negative serum pregnancy test, if of child-bearing potential
* If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
* Participation in other research protocols does not exclude a patient from participation in this study
Exclusion Criteria:
* Hemoglobin \<10 g/dL
* Plasma albumin \<3 g/dL
* GOG performance status \>2
* Plasma glucose \>200 mg/dL
* Renal insufficiency with plasma creatinine \>1.6
* Uncontrolled hypertension
* Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate
* Pregnancy
For Stage 2:
* Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
* Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02285192
Study Brief:
Protocol Section:
NCT02285192