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ICHOM Breast Cancer - Baseline - Patient-reported

- 9/20/21 - 1 form, 4 itemgroups, 29 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Baseline clinical factors, Degree of health
ICHOM Breast Cancer data collection Version 1.0.1 Revised: March 30, 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 Breast Cancer, the following treatment approaches (or interventions) are covered by our Standard Set. Conditions*: All patients (men and women) with newly pathologically diagnosed invasive breast cancer (stage I-IV) and ductal carcinoma in situ (DCIS). *Excluded Conditions: Rare tumors (e.g. phyllodes tumor), lobular carcinoma in situ (LCIS) and patients with recurrent disease at baseline will be excluded. Treatment approaches: (Reconstructive) Surgery | Radiotherapy | Chemotherapy | Hormonal Therapy | Targeted Therapy | This document contains the Baseline - Patient-reported form. It has to be filled in before first doctor's visit. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, EORTC QLQ-BR23, EORTC QLQ-LMC21). As a permission is needed for use of these questionnaires, only the total score of each will be included in this version of the standard set. More information can be found at http://groups.eortc.be/qol/eortc-qlq-c30 BREAST-Q Patient Reported Outcomes Instrument (BREAST-Q). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information, please visit: https:// eprovide.mapi-trust.org/instruments/ breast-q#contact_and_conditions_of_ use Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES). As a permission is needed for use of this questionnaire, only the total score of each will be included in this version of the standard set. For more information see http://www.facit.org/facitorg/ questionnaires. Reference: Ong WL, Schouwenburg MG, van Bommel AC, et al. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017;3(5):677–685. doi:10.1001/jamaoncol.2016.4851 The Standard set of ICHOM was supported by the Dutch Dnstitute for Clinical Auditing, Onderlinge Waarborgmaatschappij Centrale Zorgverzekeraars group, Ramsay Health Care and Karolinska Institute. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Breast Cancer - Baseline - Clinical-reported

- 4/30/20 - 1 form, 4 itemgroups, 31 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Baseline clinical factors, Baseline tumor factors
ICHOM Breast Cancer data collection Version 1.0.1 Revised: March 30, 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 Breast Cancer, the following treatment approaches (or interventions) are covered by our Standard Set. Conditions*: All patients (men and women) with newly pathologically diagnosed invasive breast cancer (stage I-IV) and ductal carcinoma in situ (DCIS). *Excluded Conditions: Rare tumors (e.g. phyllodes tumor), lobular carcinoma in situ (LCIS) and patients with recurrent disease at baseline will be excluded. Treatment approaches: (Reconstructive) Surgery | Radiotherapy | Chemotherapy | Hormonal Therapy | Targeted Therapy | This document contains the Baseline - Clinical-reported form. It has to be filled in at first doctor's visit of patient and repeated at the beginning of therapies or in case of recurrence. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, EORTC QLQ-BR23, EORTC QLQ-LMC21). As a permission is needed for use of these questionnaires, only the total score of each will be included in this version of the standard set. More information can be found at http://groups.eortc.be/qol/eortc-qlq-c30 BREAST-Q Patient Reported Outcomes Instrument (BREAST-Q). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information, please visit: https:// eprovide.mapi-trust.org/instruments/ breast-q#contact_and_conditions_of_ use Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES). As a permission is needed for use of this questionnaire, only the total score of each will be included in this version of the standard set. For more information see http://www.facit.org/facitorg/ questionnaires. Reference: Ong WL, Schouwenburg MG, van Bommel AC, et al. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017;3(5):677–685. doi:10.1001/jamaoncol.2016.4851 The Standard set of ICHOM was supported by the Dutch Dnstitute for Clinical Auditing, Onderlinge Waarborgmaatschappij Centrale Zorgverzekeraars group, Ramsay Health Care and Karolinska Institute. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Breast Cancer NCT00433589 Treatment - Baseline information - 2499196v1.0 - Baseline information

- 1/9/15 - 1 form, 3 itemgroups, 19 items, 1 language
Itemgroups: Header, Baseline information, Footer Module
Baseline information Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=196BF5B8-7A98-4811-E044-0003BA3F9857

Breast Cancer ALTTO Study BIG 2-06/N063D NCT00490139 - Outcome of Pregnancy Breast Cancer NCT00490139

- 9/20/21 - 1 form, 44 itemgroups, 314 items, 2 languages
Itemgroups: Header Module, Registration Header, Submission Details, Contact Person For Pathology Results, Patient Demographics, Eligibility Screening Form, Randomization, Informed consent, Gynecological status, Patient Status, ECG, Cardiac Monitoring, Local Her2 Results, Hormonal Receptor Status, History Of Primary Breast Cancer, History Of Primary Cancer (continued), Sentinel Node Sampling, Most Extensive Primary Surgery, Axillary Node Dissection, Chemotherapy, Previous Or Current Cardiovascular Disease, ECG, Translational Research, Central Her2 Testing Form - FISH, Central Her2 Testing Form - IHC, Radiotherapy, Hormone therapy, Concomitant Treatment, Administration of Study Drug, Chemotherapy, Targeted Therapy, Hormonetherapy, Radiotherapy, Surgery, Adverse Event (AE), Second Primary Malignancy and Contralateral Breast Cancer, Patient Status, Cardiac Monitoring, Mammogram, Hematoly and Biochemistry, Survival Follow-Up, Treatment Completion, Additional Comments , Death Form
A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer Outcome of Pregnancy - 2764926v1.0 NCT00490139

Response - Phase II Breast Cancer - Baseline Solid Tumor Evaluation Form - 2550519v1.0 - Phase II Breast Cancer - Baseline Solid Tumor Evaluation Form

- 1/9/15 - 1 form, 5 itemgroups, 28 items, 1 language
Itemgroups: CRF Header, Form Administration, Target Lesion(s) Baseline Evaluation , Nontarget Lesion(s) Baseline Evaluation, Comments
Phase II Breast Cancer - Baseline Solid Tumor Evaluation Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=23E4B808-D135-56BC-E044-0003BA3F9857

Breast Cancer NCT01242800 On-Study - E2108 Baseline Disease Evaluation Form (RECIST 1.1) - 3129560v1.0 - E2108 Baseline Disease Evaluation Form (RECIST 1.1)

- 1/9/15 - 1 form, 8 itemgroups, 38 items, 1 language
Itemgroups: Header Module, Header, Amended Data, TARGET LESIONS, TARGET LESIONS - NON NODAL, TARGET LESIONS - NODAL, NONTARGET LESIONS, Footer Module
E2108 Baseline Disease Evaluation Form (RECIST 1.1) Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E091CE3-49A1-4A3C-E040-BB89AD4304A1

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D - study documentation

- 9/20/21 - 1 form, 47 itemgroups, 279 items, 2 languages
Itemgroups: ChecklistDemographics, Header Module, Registration Header, Registration characteristics, Contact Person For Pathology Results, Patient Demographics, Eligibility Screening Form, Randomization, Informed consent, Gynaecological examination, Patient Status, ECG, Cardiac Monitoring, Local Her2 Results, Hormonal Receptor Status, History Of Primary Breast Cancer, History Of Primary Cancer (continued), Sentinel Node Sampling, Most Extensive Primary Surgery, Axillary Node Dissection, Chemotherapy, Previous Or Current Cardiovascular Disease, ECG, Translational Research, Central Her2 Testing Form - FISH, Central Her2 Testing Form - IHC, Radiotherapy, Hormonetherapy, Concomitant Treatment, Administration of Study Drug, Post-Event-Treatment, Chemotherapy, Targeted Therapy, Hormonetherapy, Radiotherapy, Surgery, Adverse Event (AE), Second Primary Malignancy and Contralateral Breast Cancer, On Study - Years 6, 7, 8, 9, and 10, Patient Status, Cardiac Monitoring, Mammogram, Hematoly and Biochemistry, Survival Follow-Up, Treatment Completion, Additional Comments , Death Form
A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

CALGB BASELINE SOLID TUMOR EVALUATION FORM NCT00770809

- 6/18/15 - 1 form, 5 itemgroups, 25 items, 1 language
Itemgroups: Header, Patient demographics, TARGET LESION(S) BASELINE EVALUATION, NON-TARGET LESION(S) BASELINE EVALUATION, Footer module
CALGB BASELINE SOLID TUMOR EVALUATION FORM NCT00770809 Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3CB305DE-3347-5C21-E044-0003BA3F9857

ECOG Baseline Disease Evaluation Form (RECIST) NCT00520975

- 6/18/15 - 1 form, 6 itemgroups, 30 items, 1 language
Itemgroups: Header, Patient demographics, Data amendment, TARGET LESIONS, NONTARGET LESIONS, Comments
ECOG Baseline Disease Evaluation Form (RECIST) NCT00520975 First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=171FC80B-42C1-397E-E044-0003BA3F9857

CALGB 40503 BASELINE SOLID TUMOR EVALUATION FORM NCT00601900

- 6/18/15 - 1 form, 5 itemgroups, 25 items, 1 language
Itemgroups: Header, Patient demographics, TARGET LESION(S) BASELINE EVALUATION, NON-TARGET LESION(S) BASELINE EVALUATION, Footer module
CALGB 40503 BASELINE SOLID TUMOR EVALUATION FORM NCT00601900 Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=240398A9-9A49-483A-E044-0003BA3F9857

CALGB: Baseline Solid Tumor Evaluation Form NCT00053339

- 6/3/15 - 1 form, 5 itemgroups, 25 items, 1 language
Itemgroups: CALGB Information, Patient clinical trial data, Target Lesion(s) Baseline Evaluation, Non-target lesion(s) Baseline Evaluation, CCRR MODULE
CALGB: Baseline Solid Tumor Evaluation Form NCT00053339 Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D1562-3BF3-473F-E034-0003BA0B1A09

ECOG Baseline Disease Evaluation Form (RECIST), E2100

- 5/23/15 - 1 form, 5 itemgroups, 20 items, 1 language
Itemgroups: ECOG Clinical trial administrative data, TARGET LESIONS, NONTARGET LESIONS, Comments, CCRR MODULE
ECOG Baseline Disease Evaluation Form (RECIST), E2100 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC353A38-9217-267B-E034-0003BA12F5E7

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