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The purpose of the SENTRY (Stability Enhanced Transcriptional Analytics) Study is to test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses ovarian cancer. Using retrospective data, the investigators have developed an approach that appears to accurately classify ovarian cancer with relatively high sensitivity and specificity. The SENTRY Study will build upon these retrospective analyses to prospectively recruit women with ovarian cancer or an ovarian mass (and healthy control women), obtain platelet RNA samples from whole blood, and perform validation analyses to test our hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215) |
| ||
| Control Women without Ovarian Cancer (n=30) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet RNA expression | Diagnostic Test | The SENTRY (Stability Enhanced Transcriptional Analytics) Study is to test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses ovarian cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Early-Stage Ovarian Cancer Detection | The goal is to determine if changes in platelet RNA expression accurately diagnoses ovarian cancer. This outcome will report the number of true positive, true negative, false positive, and false negative results from this assay. | Following informed consent (study visit 1, day 1). |
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Study Populations 1 and 2: Women with a Recent Diagnosis of an Ovarian or Pelvic Mass (n=215)
Inclusion Criteria:
Exclusion Criteria:
Study Population 3: Control Women without Ovarian Cancer (n=30)
Inclusion Criteria:
1. Women aged 21 years or older
Exclusion Criteria:
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Participants will be patients in the Huntsman Cancer Hospital Clinics in Salt Lake City, Utah.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syrenna Lisonbee | Contact | 801-585-0161 | Syrenna.Lisonbee@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Theresa Werner, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
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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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This study will obtain platelet RNA samples from whole blood.
| 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 |