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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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ICHOM Lung Cancer - Follow-up - Clinical Form

- 9/20/21 - 1 form, 8 itemgroups, 64 items, 1 language
Itemgroups: Administrative data, Degree of health, Baseline tumor factors, Treatment Factors, Treatment Variables, Acute complications of treatment, Survival, Quality of death
ICHOM Lung 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. For Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains Follow-up - Clinical Form. It includes different points in time: After treatment, After surgery, Update at least annually, 1 year post initiation of treatment and Tracked ongoing annually for life (when hospital is able to track this ongoing). Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Lung Cancer NCT00955175

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Criteria
Hypofractionated 3-Dimensional Radiation Therapy in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. ICORG 99-09; ODM derived from: https://clinicaltrials.gov/show/NCT00955175

Eligibility Lung Cancer NCT00003053

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Criteria
Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed; ODM derived from: https://clinicaltrials.gov/show/NCT00003053

RTOG-0412 I1 Rev1: Initial Evaluation Form NCT00113386

- 9/20/21 - 1 form, 4 itemgroups, 44 items, 1 language
Itemgroups: Header, PRE-TREATMENT CHACTERISTICS, LYMPH NODE ASSESSMENT, Comments
RTOG-0412 I1 Rev1: Initial Evaluation Form NCT00113386 Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ED65A888-399B-7059-E034-0003BA3F9857

Lung Cancer NCT00324805 Eligibility - E1505 Registration Worksheet (step 1) - 2555093v1.0 - E1505 Registration Worksheet (step 1)

- 9/20/21 - 1 form, 3 itemgroups, 29 items, 1 language
Itemgroups: Eligibility, Race, Patient Demographics / Pre-Treatment Characteristics
E1505 Registration Worksheet (step 1) Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24E23D06-7E57-43FF-E044-0003BA3F9857

Pathology - Lung Cancer - North Central Cancer Treatment Group N0723 Pathology Reporting Form - 2731651v1.0 - Lung Cancer - North Central Cancer Treatment Group N0723 Pathology Reporting Form

- 9/20/21 - 1 form, 9 itemgroups, 59 items, 1 language
Itemgroups: Header Module, Pathology Reporting, Lung Surgery, Disease Characteristics, Disease Characteristics2, Comments and Pathology Reporting, EGFR FISH Status, EGFR IHC Status, Comments and Pathology Reporting2
North Central Cancer Treatment Group N0723 Pathology Reporting Form; ***This CRF DELETED FROM STUDY, so no response to initial CDE-compliance review.*** Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=46FF63E8-1059-1831-E044-0003BA3F9857

Lung Cancer NCT00738881 On-Study - North Central Cancer Treatment Group N0723 On-Study Form - 2731649v1.0 - North Central Cancer Treatment Group N0723 On-Study Form

- 9/20/21 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Header Module, Description of Primary Disease, Chronology of Diagnoses, Metastatic Site(s), Previous Surgery Related To The Tumor, Prior Radiation Therapy, Prior systemic therapy, Descriptive Factors
North Central Cancer Treatment Group N0723 On-Study Form Pemetrexed or Erlotinib as Second-Line Therapy in Treating Patients With Advanced Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=46FF63E8-1055-1831-E044-0003BA3F9857

NSCLC (NCT00049543) - Eligibility Checklist and Initial Evaluation NSCLC (NCT00049543)

- 9/20/21 - 1 form, 10 itemgroups, 154 items, 1 language
Itemgroups: PATIENT INFORMATION, ELIGIBILITY CHECKLIST, RANDOMIZATION, HISTORY AND PHYSICAL EXAM, INVESTIGATIONS, HEMATOLOGY and BIOCHEMISTRY (baseline), DISEASE HISTORY and PRIOR TREATMENT, Adverse event, CONCOMITANT MEDICATIONS, OTHER MAJOR MEDICAL PROBLEMS
Form 1 - Eligibility Checklist and Initial Evaluation Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed NCT00049543 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

CALGB: Thoracic Lymph Node Sampling Report NCT00499330

- 9/20/21 - 1 form, 7 itemgroups, 24 items, 1 language
Itemgroups: Header, Patient demographics, Surgical Approach Right Sided Nodes, Right Sided Nodes, Surgical Approach Left Sided Nodes, Left Sided Nodes, Footer module
CALGB: Thoracic Lymph Node Sampling Report NCT00499330 Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=225E819D-890F-6685-E044-0003BA3F9857

ECOG-E1505 On-Study Form NCT00324805

- 9/20/21 - 1 form, 9 itemgroups, 56 items, 1 language
Itemgroups: ECOG clinical trial administrative data, Data amendment, Pre-Treatment Characteristics, Patients registered to receive Regimen 4 (Pemetrexed/Cisplatin), Cardiac History, NSCLC Disease Description, Resection Information, Baseline Abnormalities, Comments
ECOG-E1505 On-Study Form NCT00324805 Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=078250FE-30E9-0714-E044-0003BA3F9857

RTOG-0617 I1: Radiation Therapy Oncology Group Phase III High-dose Vs Standard-dose Conformal XRT with Chemotherapy Initial Evaluation Form NCT00533949

- 9/20/21 - 1 form, 9 itemgroups, 82 items, 1 language
Itemgroups: Clinical trial administrative data, PRE-TREATMENT CHACTERISTICS, Disease Staging, LYMPH NODE ASSESSMENT, carcinoma of the lung, Required Pretreatment Studies, PET Scan, Pretreatment Labs, Footer
RTOG-0617 I1: Radiation Therapy Oncology Group Phase III High-dose Vs Standard-dose Conformal XRT with Chemotherapy Initial Evaluation Form NCT00533949 High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24AC693F-14F6-1842-E044-0003BA3F9857

Lung Cancer NCT00113386 Quality of Life - RTOG-0412 FA: Funcation Assessment Cancer Therapy - Lung Trial Outcome Index (TOI) - 2288075v3.0 - RTOG-0412 FA: Funcation Assessment Cancer Therapy - Lung Trial Outcome Index (TOI)

- 9/20/21 - 1 form, 4 itemgroups, 32 items, 1 language
Itemgroups: MODULE 1, PHYSICAL WELL-BEING, FUNCTIONAL WELL-BEING, ADDITIONAL CONCERNS
RTOG-0412 FA: Funcation Assessment Cancer Therapy - Lung Trial Outcome Index (TOI) Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E48B0FD8-0824-0529-E034-0003BA3F9857

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