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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Swedish Bladder Cancer Registry - Cystectomy - Follow-Up

- 9/27/21 - 1 form, 5 itemgroups, 106 items, 2 languages
Itemgroups: General Information, Preoperative Data, Perioperative Data, Postoperative Data, Complications and Reoperations
Swedish Bladder Cancer Registry Healthcare Quality http://www.cancercentrum.se/vast/cancerdiagnoser/urinvagar/urinblase--och-urinvagscancer/kvalitetsregister/dokument/ Cystectomy - Follow-Up

Eligibility Prostatic Neoplasms NCT00537381

- 9/27/21 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Inclusion Criteria
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00537381

Eligibility Prostate Cancer NCT01009736

- 9/27/21 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: Inclusion Criteria
Effects of Tomato-Soy Juice on Biomarkers in Patients With Prostate Cancer Undergoing Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT01009736

Eligibility Prostate Cancer NCT00881725

- 9/27/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of Pre-operative Metformin in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00881725

Eligibility Prostate Cancer NCT00716794

- 9/27/21 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: Criteria
A Phase I/II Study of HE3235 in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00716794

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Logs/Repeats

- 9/27/21 - 1 form, 12 itemgroups, 130 items, 1 language
Itemgroups: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Urinalysis, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Repeat, Pharmacokinetic aspect, Blood, Repeat
Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Eligibility Urothelial Carcinoma NCT02278978

- 9/22/21 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02278978

ICHOM Localized Prostate Cancer - Clinical Form annually after treatment initiation

- 9/20/21 - 1 form, 4 itemgroups, 52 items, 1 language
Itemgroups: Patient ID, Treatment Variables, Acute Complications of Treatment, Survival and Disease Control
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 a Clinical Form to be used annually after salvage treatment initiation. 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 the 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.

ICHOM Localized Prostate Cancer - Clinical Form within 6 months after treatment initiation

- 9/20/21 - 1 form, 3 itemgroups, 48 items, 1 language
Itemgroups: Patient ID, Treatment Variables, Acute Complications of Treatment
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 a Clinical Form to be used 6 months after primary treatment initiation. Surveys 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 the Localized Prostate Cancer Standard Set by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Carcinoma, Renal Cell NCT02454478

- 9/20/21 - 1 form, 2 itemgroups, 35 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Study of Lenvatinib in Combination With Everolimus in Patients With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC); ODM derived from: https://clinicaltrials.gov/show/NCT02454478

Eligibility Metastatic Castration-Resistant Prostate Cancer NCT02405858

- 9/20/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02405858

Eligibility Carcinoma, Renal Cell NCT01441388

- 9/20/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study Of Crizotinib Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.; ODM derived from: https://clinicaltrials.gov/show/NCT01441388

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