AOA-PRT-0001: Collection and Banking of Blood Samples for the Study of Female Gynecological Diseases
Gynecologic Cancers
Ovarian Cancer
Biomarker/Laboratory analysis
Tissue collection/Repository
Other
Summary
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.
Objectives
The objective of this protocol is to collect blood and store blood sample derivatives from women with gynecological diseases, including from women with signs and symptoms of OC.
Eligibility
Subjects meeting the following inclusion criteria, but not meeting any of the exclusion criteria will be enrolled in this study. Confirmation of eligibility criteria will be documented in study case report forms (CRFs).
Inclusion Criteria
1. Subject is biologically female and at least 22 years of age and capable of informed consent
2. Subject has at least one ovary and/or fallopian tube.
3. Subject has a positive Ovarian Cancer Symptom Index as assessed by the investigator.
a. 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.
4. Subjects must provide informed consent in accordance with the IRB requirements at each institution.
In addition, Cohort 2 has the following criteria:
5. Subject has confirmed Ovarian Cancer diagnosis via a pathological finding.
Exclusion Criteria
1. Participant is pregnant (self-reported, no special study pregnancy testing needed).
2. Participant has received a previous or current diagnosis of any cancer (excluding non-melanoma skin cancers).
3. Participant is undergoing chemotherapy or radiation treatment.
Cohort 1 exclusion criteria:
4. Participant has a scheduled surgery for suspicion of OC prior to enrollment.
Cohort 2 exclusion criteria:
5. Participant has already undergone debulking surgery
Treatment Sites in Georgia
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