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Baseline Clinical Form

1 forms  
  1. StudyEvent: ODM
    1. Baseline Clinical Form
Patient ID
Description

Patient ID

Alias
UMLS CUI-1
C1269815
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical TYPE: Numerical RESPONSE OPTIONS: According to institution

Data type

integer

Alias
UMLS CUI [1]
C1269815
Baseline Tumor Factors
Description

Baseline Tumor Factors

Alias
UMLS CUI-1
C0475752
UMLS CUI-2
C1442488
Indicate the initial date of histological diagnosis
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical or administrative data TYPE: Date by DD/MM/YYYY RESPONSE OPTIONS: DD/MM/YYYY

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C0600139
Indicate most recent PSA value before histological diagnosis
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

float

Measurement units
  • ng/mL
Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0679557
UMLS CUI [1,4]
C0600139
ng/mL
Indicate the clinical tumor stage (per AJCC 7th)
Description

Pathologic staging preferred, if available cT0: No evidence of primary tumor cT1: if not able to select cT1a, cT1b or cT1c: Clinically inapparent tumor neither palpable nor visible by imaging cT1a: Tumor incidental histologic finding in 5 percent or less of tissue resected cT1b: Tumor incidental histologic finding in more than 5 percent of tissue resected cT1c: Tumor identified by needle biopsy (eg, because of elevated PSA) cT2: if not able to select cT2a, cT2b or cT2c: Tumor confined within prostate* cT2a: Tumor involves one-half of one lobe or less cT2b: Tumor involves more than one-half of one lobe but not both lobes cT2c: Tumor involves both lobes cT3: if not able to select cT3a, cT3b or cT3c: Tumor extends through the prostate capsule cT3a: Extracapsular extension (unilateral or bilateral) cT3b: Tumor invades seminal vesicle(s) cT4: Tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall cTX: Primary tumor cannot be assessed INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0441915
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0600139
Indicate the clinical nodal stage (per AJCC 7th)
Description

Pathologic staging preferred, if available cNo: regional lymph node metastasis cN1: Metastasis in regional lymph node(s) cNX: Regional lymph nodes were not assessed INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0456532
UMLS CUI [1,2]
C0441915
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C0600139
Indicate the number of cores taken during the patient’s biopsy
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

integer

Alias
UMLS CUI [1,1]
C1275862
UMLS CUI [1,2]
C0600139
Indicate the number of cores that are positive
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Numerical

Data type

integer

Alias
UMLS CUI [1,1]
C4528268
UMLS CUI [1,2]
C0600139
Indicate the greatest percentage cancer involvement in any one biopsy core
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C1272841
%
If yes, indicate the primary Gleason score at time of initial diagnosis
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

integer

Alias
UMLS CUI [1,1]
C1273604
UMLS CUI [1,2]
C0005558
If yes, indicate the secondary Gleason score at time of initial diagnosis
Description

INCLUSION CRITERIA: All patients TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

integer

Alias
UMLS CUI [1,1]
C1273605
UMLS CUI [1,2]
C0005558
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Similar models

Baseline Clinical Form

1 forms
  1. StudyEvent: ODM
    1. Baseline Clinical Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient ID
C1269815 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Item Group
Baseline Tumor Factors
C0475752 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Date of histological diagnosis
Item
Indicate the initial date of histological diagnosis
date
C2316983 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Most recent PSA value before histological diagnosis
Item
Indicate most recent PSA value before histological diagnosis
float
C0138741 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0679557 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
Item
Indicate the clinical tumor stage (per AJCC 7th)
integer
C0441915 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Clinical tumor stage
Code List
Indicate the clinical tumor stage (per AJCC 7th)
CL Item
cT0  (0)
C2982634 (UMLS CUI-1)
(Comment:en)
CL Item
cT1  (1)
C2982635 (UMLS CUI-1)
(Comment:en)
CL Item
cT1a  (2)
C2982636 (UMLS CUI-1)
(Comment:en)
CL Item
cT1b  (3)
C2982637 (UMLS CUI-1)
(Comment:en)
CL Item
cT1c  (4)
C2982638 (UMLS CUI-1)
(Comment:en)
CL Item
cT2  (5)
C2982639 (UMLS CUI-1)
(Comment:en)
CL Item
cT2a  (6)
C2982640 (UMLS CUI-1)
(Comment:en)
CL Item
cT2b  (7)
C2982641 (UMLS CUI-1)
(Comment:en)
CL Item
cT2c (8)
C2982642 (UMLS CUI-1)
(Comment:en)
CL Item
cT3  (9)
C2982643 (UMLS CUI-1)
(Comment:en)
CL Item
cT3a  (10)
C2982644 (UMLS CUI-1)
(Comment:en)
CL Item
cT3b  (11)
C2982645 (UMLS CUI-1)
(Comment:en)
CL Item
cT4  (12)
C2982646 (UMLS CUI-1)
(Comment:en)
CL Item
cTX  (13)
C2982633 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate the clinical nodal stage (per AJCC 7th)
integer
C0456532 (UMLS CUI [1,1])
C0441915 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
Clinical nodal stage
Code List
Indicate the clinical nodal stage (per AJCC 7th)
CL Item
cN0  (0)
C2982649 (UMLS CUI-1)
(Comment:en)
CL Item
cN1  (1)
C2982650 (UMLS CUI-1)
(Comment:en)
CL Item
cNX (2)
C2982648 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Number of biopsy cores taken
Item
Indicate the number of cores taken during the patient’s biopsy
integer
C1275862 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Number of biopsy cores positive
Item
Indicate the number of cores that are positive
integer
C4528268 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Greatest percentage involvement
Item
Indicate the greatest percentage cancer involvement in any one biopsy core
integer
C1272841 (UMLS CUI [1])
Gleason score: Primary
Item
If yes, indicate the primary Gleason score at time of initial diagnosis
integer
C1273604 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Gleason score: Secondary
Item
If yes, indicate the secondary Gleason score at time of initial diagnosis
integer
C1273605 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
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