ID

40525

Description

LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Localized prostate cancer Treatment Approaches: Active Surveillance | Watchful Waiting | Radical Prostatectomy* | External Beam Radiation Therapy* | Androgen Deprivation Therapy (ADT)* | Focal Therapy* | Other* * These should also be collected as salvage treatments where necessary This ODM-file contains Baseline Clinical Form. To be used at baseline, i.e., post-diagnosis, pre-treatment. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC-CP rather than the EPIC-26, we recommend using the same variable IDs as the corresponding EPIC-26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed. Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ- PR25): The EORTC QLQ-PR25 is free for all health care organizations, but a license is needed for use. Therefore it will not be integrated in this Version of the questionnaire. For more information, please visit http://groups.eortc.be/qol/eortc-qlq-c30 . ICHOM was supported for this Localized Prostate Cancer Standard Set by the Movember Foundation. Publication: Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67(3):460‐467. doi:10.1016/j.eururo.2014.08.075 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Link

www.ichom.org

Keywords

Versions (2)
  1. 8/21/18 8/21/18 - Sarah Riepenhausen
  2. 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder

ICHOM

Uploaded on

April 30, 2020

DOI

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License

Creative Commons BY-NC 4.0
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ICHOM Localized Prostate Cancer

English

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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