Form:Prostate Reference Set Clinical v1.0


CDE IDCDE Description
* 1063Site Participant ID (Go To: 422)
* 422EDRN Site ID (Go To: 423)
* 423EDRN Protocol ID (Go To: 1292)
   1292Height [in inches] (What is your total current height in inches?) (Go To: 1295)
   1295Weight [in pounds] (What is your current weight [in pounds]? (Go To: 578)
   578Age at specimen collection (Go To: 1576)
   1576American Urological Association (AUA) symptom score: (Go To: 1699)
   1699Date of current prostate biopsy (MM/DD/YYYY): (Go To: 2705)
   2705Indication for current prostate biopsy (Check all that apply.) (Go To: 1578)
 
Permissible Values (value):Rising PSA (1)
 
 Elevated PSA (2)
 
 Abnormal DRE (3)
 
 Abnormal biopsy (4)
 
 Atypia (5)
 
 Atypical small acinar proliferation (ASAP) (6)
 
 Family history (7)
 
 High grade PIN (8)
 
 Other, specify: (97)
   1578Indication for prostate biopsy, other specify: (Go To: 2643)
   2643Reviewed by study personnel? (Go To: 979)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown (99)
   979Date of digital rectal exam (DRE) (MM/DD/YYYY): (Go To: 976)
   976Digital rectal exam results: (Go To: 2173)
 
Permissible Values (value):Normal (1)
 
 Enlarged, benign (3)
 
 Enlarged/Asymmetry (4)
 
 Abnormal (firm/induration/nodularity), suspicious for cancer (5)
 
 Unknown/refused (99)
   2173Amount of induration/nodularity on digital rectal exam (DRE), if not normal: (Go To: 1582)
 
Permissible Values (value):< 50% right (1)
 
 ≥ 50% right (2)
 
 < 50% left (3)
 
 ≥ 50% left (4)
 
 Bilateral (5)
 
 Abnormal DRE but extent not specified (6)
   1582Date of PSA: (Go To: 947)
   947PSA (ng/ml) (Go To: 1692)
   1692Prostate size (by TRUS): (Go To: 1581)
   1581Hypoechoic or suspicious foci seen? (Go To: 1583)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1583Number of cores biopsied on left: (Go To: 1584)
   1584Number of cores biopsied on right: (Go To: 1693)
   1693Number of other cores biopsied: (Go To: 1585)
   1585Types of other cores biopsied, specify: (Go To: 1586)
   1586Presence of prostate adenocarcinoma: (Go To: 1587)
 
Permissible Values (value):Malignancy absent (1)
 
 Malignancy present (2)
   1587Number of positive cores involved on left: (Go To: 1588)
   1588Number of positive cores involved on right: (Go To: 1589)
   1589Primary Gleason grade: (Go To: 1590)
   1590Secondary Gleason grade: (Go To: 1696)
   1696Tertiary Gleason Pattern: (Go To: 1697)
   1697Overall Gleason Score: (Go To: 1591)
   1591Perineural invasion: (Go To: 1592)
 
Permissible Values (value):Present (1)
 
 Absent (2)
   1592Percent of cancer in core with most cancer: (Go To: 1593)
   1593Length of core with most cancer (mm): (Go To: 975)
   975Prostate T-Stage, Clinical (Go To: 2179)
 
Permissible Values (value):T0 (2)
 
 T1 (3)
 
 T1a (4)
 
 T1b (5)
 
 T1c (6)
 
 T2 (7)
 
 T2a (8)
 
 T2b (9)
 
 T2c (10)
 
 T3 (11)
 
 T3a (12)
 
 T3b (13)
 
 T4 (14)
 
 TX (15)
   2179Prostate N-Stage, Clinical: (Go To: 1694)
 
Permissible Values (value):NX (1)
 
 N0 (2)
 
 N1 (5)
   1694Prostate M-Stage, Clinical : (Go To: 984)
 
Permissible Values (value):MX (1)
 
 M0 (2)
 
 M1 (3)
 
 M1a (4)
 
 M1b (5)
 
 M1c (6)
   984High grade prostatic intraepithelial neoplasia (PIN)? (Go To: 1595)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1595Inflammation present? (Go To: 1596)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1596Atypical small acinar proliferation (ASAP)? (Go To: 1597)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1597Atypia/Suspicious? (Go To: 1598)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1598Atrophy? (Go To: End of Form)
 
Permissible Values (value):No (0)
 
 Yes (1)