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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT01787656
Eligibility Criteria:
Inclusion Criteria:
1. Must be fully consented to the collection of the samples in writing (completed consent forms).
2. Age Criteria: Women age 50 and older who are post menopausal (defined as 12 months past last menstrual period).
3. Must have: Diagnosis of an adnexal mass or a suspicion of ovarian cancer, or a suspected fallopian tube or primary peritoneal cancer.
4. Must have a uterus and cervix.
5. Surgery for the adnexal mass must be anticipated. (Only patients with an adnexal mass requiring surgery will be eligible).
Exclusion Criteria:
1. Any subject who has a condition that would increase the risk associated with the standard sampling procedures (Such as a pap smear, or cotton swab in vagina)
2. Prior hysterectomy.
3. Absence of adnexal mass.
4. Primary diagnosis of a cancer other than ovarian, primary peritoneal or fallopian tube.
5. Patients with grossly visible cervical cancer.
6. Previous/recent treatment for any invasive gynecologic cancer.
7. Recent chemotherapy within the prior 2 years. (recent neoadjuvant chemotherapy for ovarian cancer would exclude the patient from participation).
8. Cervical conization within the prior 6 months.
9. History of Radiation therapy to the pelvis, vagina or cervix.
10. Obvious advanced stage cancer (Stage III or IV) on presentation, if known prior to specimen collection.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT01787656
Study Brief:
Protocol Section:
NCT01787656