ID
40562
Description
ADVANCED PROSTATE CANCER DATA COLLECTION Version 2.3.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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: All patients with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment. Patients with biochemical recurrence treated with salvage therapy are referred to the localized prostate cancer set. Treatment Approaches: Hormonal Therapy | Chemotherapy | Immunotherapy | Radiopharmaceuticals | Radiation | Interventions for Complications of Local Progression This form contains clinical varibales to be assessed at baseline (Baseline index event: diagnosis of advanced Disease: Diagnosed with LPC, progresses to biochemical recurrence and is not eligible for salvage thearpy or has been treated with salvage thearpy; Diagnosed with LPC, progresses to metastatic disease; Diagnosed with metastatic disease at time of diagnosis). Questionnaires used in this standard set: 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 (according to ICHOM). 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-C30): For use of the EORTC QLQ-C30 a license is needed, therefore the questions will not be part of this version of the standard set. (eortc.be) The following paper has been published about development of this standard set: Morgans AK, van Bommel ACM, Stowell C, Abrahm JL, Basch E, Bekelman JE, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015 Nov;68(5):891–8. For the standard set ICHOM has been supported by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.
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Versions (2)
- 11/29/18 11/29/18 - Sarah Riepenhausen
- 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder
ICHOM
Uploaded on
April 30, 2020
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License
Creative Commons BY-NC 4.0
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ICHOM Advanced Prostate Cancer
Baseline Clinical Form
- StudyEvent: ODM
Description
Demographic Factors
Alias
- UMLS CUI-1
- C1704791
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical or patient-reported TYPE: Date by DD/MM/YYYY
Data type
date
Measurement units
- DD/MM/YYYY
Alias
- UMLS CUI [1]
- C0421451
Description
Height and weight are used to calculate BMI INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Numerical value RESPONSE OPTIONS: Numerical value of height in cm or in
Data type
float
Alias
- UMLS CUI [1]
- C0005890
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Description
Height and weight are used to calculate BMI INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Numerical value RESPONSE OPTIONS: Numerical value of weight in kg or lbs
Data type
float
Alias
- UMLS CUI [1]
- C0005910
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Description
Baseline Clinical Factors
Alias
- UMLS CUI-1
- C0449440
- UMLS CUI-2
- C1442488
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: Numerical value of hemoglobin level in g/L
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1,1]
- C0518015
- UMLS CUI [1,2]
- C0011900
Description
Baseline Tumor Factors
Alias
- UMLS CUI-1
- C0475752
- UMLS CUI-2
- C1442488
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical RESPONSE OPTIONS: Numerical value of PSA ng/mL
Data type
float
Measurement units
- ng/mL
Alias
- UMLS CUI [1]
- C0201544
Description
Pathologic staging preferred, if available cT0: No evidence of primary tumor cT1: if not able to select T1a, T1b or T1c: 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 T2a, T2b or T2c: 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 T3a, T3b or T3c: 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: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600139
- UMLS CUI [1,2]
- C1300072
- UMLS CUI [1,3]
- C0205210
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: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600139
- UMLS CUI [1,2]
- C0456532
- UMLS CUI [1,3]
- C0205210
Description
Pathologic staging preferred, if available pT2: if not able to select T2a, T2b or T2c: Organ confined pT2a: Unilateral, one-half of one side or less pT2b: Unilateral, involving more than one-half of side but not both sides pT2c: Bilateral disease pT3: if not able to select T3a, T3b: Extraprostatic extension pT3a: Extraprostatic extension or microscopic invasion of bladder neck pT3b: Seminal vesicle invasion pT4: Invasion of rectum, levator muscles, and/or pelvic wall pTX: Primary tumor cannot be assessed INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600139
- UMLS CUI [1,2]
- C1300072
- UMLS CUI [1,3]
- C1521733
Description
Pathologic staging preferred, if available pN0: No positive regional nodes pN1: Metastases in regional node(s) pNX: Regional nodes not sampled INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600139
- UMLS CUI [1,2]
- C0456532
- UMLS CUI [1,3]
- C1521733
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1]
- C0332326
Description
INCLUSION CRITERIA: All patients, If answered 'yes' on Gleason score (GLEASON) TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: 2-10
Data type
integer
Alias
- UMLS CUI [1,1]
- C0332326
- UMLS CUI [1,2]
- C1273604
Description
INCLUSION CRITERIA: All patients, If answered 'yes' on Gleason score (GLEASON) TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: 2-10
Data type
integer
Alias
- UMLS CUI [1,1]
- C0332326
- UMLS CUI [1,2]
- C1273605
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1]
- C0807944
Description
High burden is indicated as any of the following criteria (from: CHAARTED (randomized clinical trial in the US): - Visceral metastases (extranodal) - Bone metastases with at least 4 bone lesions OR at least 1 bone lesion outside of the vertebral column or pelvis. INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1]
- C0449279
Description
Treatment Factors
Alias
- UMLS CUI-1
- C0679853
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0033573
Description
INCLUSION CRITERIA: All patients, If answered 'yes' on prior prostatectomy (prostatectx) TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Data type
date
Measurement units
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0033573
- UMLS CUI [1,3]
- C0011008
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0279134
- UMLS CUI [1,2]
- C1708063
Description
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0279134
- UMLS CUI [1,2]
- C1706721
- UMLS CUI [2,1]
- C0279134
- UMLS CUI [2,2]
- C0085405
Description
Use of any of the following treatments to induce castrate levels of serum testosterone: 1. LHRH or GnRH agonist or antagonist 2. Bilateral orchiectomies INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1]
- C0279492
Description
Any medication that treats the prostate cancer taken by mouth, through a vein, or injected, other than ADT INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1,1]
- C1515119
- UMLS CUI [1,2]
- C1514463
Description
Both anti-resorptive medications or denosumab are relevant INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Data type
integer
Alias
- UMLS CUI [1]
- C0012544
- UMLS CUI [2]
- C3839270
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