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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU 85B10 | Other Identifier | Wake Forest University Health Sciences |
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This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University.
This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University. Men scheduled for biopsy will be approached by the study nurse who will explain the study and invite the men to participate. After the patients provide written consent, she/he will obtain the following information from the patient chart: age, race (self-report, white, black, other), height, weight (for determination of Body Mass Index, a variable reported to influence PSA). Blood draw for study analytes will be coordinated with routine blood draw for PSA testing to minimize the need for an additional needle stick. A copy of the informed consent is given to the patient and the original is placed in a file for the P.I.
The biopsy status of men at the time they are invited to participate is unknown. Men are "sorted" into cancer and non-cancer groups only after their biopsies are read. Serum samples are sent to the Department of Laboratory Medicine at Wake Forest. All assays are performed "in house". Based on consultation with our urologists, we anticipate that approximately 30% of the biopsies will be positive (i.e., prostate cancer). The majority (approximately 70%) will be negative (benign). Approximately 1-2% of the biopsies may be classified as "indeterminate". Because there will not be a sufficient number of "indeterminate" pathologies to be treated as a separate category, this group will not be analyzed further. However, men with "indeterminate" biopsies are eligible for the study if they are re-biopsied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Undergoing Prostate Biopsy | Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This study has no intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the relationship of calcium and PTH levels to PSA levels in patients receiving a prostate biopsy. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Men > 40 years old scheduled for a prostate biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Ram Pathak, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forset University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Serum samples for measurement of PTHrP
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |