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Epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer, is the deadliest gynecologic malignant neoplasm with a 5-year relative survival of approximately 50%. This study will evaluate the concordance in folate receptor alpha (FRa) immunohistochemistry (IHC) in adult female participants with ovarian cancer.
Archived tissue biopsies will be tested for FRa and data from approximately 1,000 participants will be collected. This is a retrospective study and testing will be performed prospectively on archived samples.
Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 1 Year.
There is no additional burden for participants in this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Banked Tissue Samples Undergoing Chart Review | Banked tissue samples undergoing chart review and retrospective folate receptor alpha (FRa) testing of tissue biopsies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central) | FRa positive overexpression is defined as: tumor cell membrane staining of at least 75% with a 2+ and/or 3+ staining, or FRa negative as: tumor cell membrane staining of less than 75% with a 2+ and/or 3+ staining. | Up to Approximately 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is surgical or biopsy sample from an adult female with tumoral High Grade Serous Ovarian Cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebekah Taylor | Contact | (847) 937-8000 | rebekah.taylor@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |