Gynecological Cancer
AOA-PRT-0001: Collection and Banking of Blood Samples for the Study of Female Gynecological Diseases
Description
This is a prospective, multi-site, sample and clinical data collection study that will enroll up to 5,000 adult biologically female subjects for biospecimen banking that present with signs and symptoms of OC as described in the subject eligibility.
Inclusion Notes
Inclusion Criteria
Subject is biologically female and at least 22 years of age and capable of informed consent
Subject has at least one ovary and/or fallopian tube.
Subject has a positive Ovarian Cancer Symptom Index as assessed by the investigator.
A positive Symptom Index (as per Appendix A) is defined as a woman having one or more of the following symptoms on more than or equal to 13 days per month but for less than 1 year; abdominal/pelvic pain, feeling full quickly or unable to eat normally, abdominal bloating or increased abdomen size.
Subjects must provide informed consent in accordance with the IRB requirements at each institution.
In addition, Cohort 2 has the following criteria:
Subject has confirmed Ovarian Cancer diagnosis via a pathological finding.
Start Date
Tuesday, December 17, 2024
Principal / Contact Name
Sarah E. Gill, MD