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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 03319 | Other Identifier | Wake Forest Baptist Comprenhensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| NCI-2019-04690 | Other Identifier | National Cancer Institute |
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Issues in reserving MRI scanner
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to measure the hypoxia (low oxygen condition) in prostate cancers and its effect in survival. In this study, investigators will assess hypoxia by magnetic resonance imaging (MRI) and create a hypoxia score. Investigators will study the hypoxia score and how it correlates (if any) to the disease aggressiveness as well as its effect on the treatment outcomes.
Primary Objective(s):
Secondary Objective(s):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (MRI biospecimen collection) | Experimental | Patients undergo MRI over 15 minutes before standard of care surgery. Patients also undergo collection of blood samples during MRI and at the time of surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draws | Other | Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in Tumor Hypoxia Scores Between Subgroups | Using MRI parameters including apparent diffusion coefficient and fractional blood value four race/score combination groups (African-Americans with Gleason score 6; African-Americans with Gleason score greater than or equal to 7; Caucasians with Gleason score 6; and Caucasian with Gleason score greater than or equal to 7) to calculate the correlation coefficients estimates between hypoxic scores using Pearson correlation coefficient and Spearman's rank correlation coefficient. | 30 days |
| Number of Biomarkers Expressed | Expression of proliferation biomarkers (Ki-67 and PCNA) to calculate the correlation coefficients estimates between expression of proliferation biomarkers using Pearson correlation coefficient and Spearman's rank correlation coefficient. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ExoHypoxic Concentrations in Plasma | The associations between hypoxic score and candidate biomarkers for ExoHypoxic concentration (number per milliliter plasma) will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted. | 30 days |
| Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gagan Deep, Ph.D | Wake Forest University Health Sciences | Principal Investigator |
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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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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Magnetic resonance imaging (MRI) | Diagnostic Test | At the beginning of study magnetic resonance imaging MRI will be completed. |
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The associations between hypoxic score and fatty acid synthase expression will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted. |
| 30 days |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |