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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

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.

Response - Baseline Brain Tumor Evaluation Form - 2291059v3.0 - Baseline Brain Tumor Evaluation Form

- 1/9/15 - 1 form, 5 itemgroups, 28 items, 1 language
Itemgroups: CRF Header, Brain: Disease at Baseline, Brain: Measurable Lesion(s) Baseline Evaluation, Brain: Non-measurable/evaluable Lesion(s) Baseline Evaluation, Comments
Baseline Brain Tumor Evaluation Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E12EBFF4-9ABA-55D4-E034-0003BA12F5E7

E3F05 Baseline Primary Brain Tumor Disease Evaluation Form NCT00978458

- 6/16/15 - 1 form, 10 itemgroups, 38 items, 1 language
Itemgroups: Header Module, Data amendment, Section I MEASURABLE LESIONS, T2/FLAIR, T1/Contrast, Section II NON-MEASURABLE LESIONS, T2/FLAIR Non-Measurable Lesions, T1/Contrast Non-Measurable Lesions, Section III, Comments
E3F05 Baseline Primary Brain Tumor Disease Evaluation Form NCT00978458 Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6C1947D6-6AFF-2C82-E040-BB89AD4371C6

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

HIV with Cancer Baseline AMC-061 NCT00890747 - Baseline Evaluation Form HIV with Cancer NCT00890747

- 5/20/15 - 1 form, 4 itemgroups, 19 items, 1 language
Itemgroups: Header Module, SOLID TUMOR/LYMPHOMA ASSESSMENT, KAPOSI'S SARCOMA ASSESSMENT, HEMATOLOGIC MALIGNANCY ASSESSMENT
AMC-061 Baseline Evaluation Form (B61) Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy NCT00890747 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=715BD918-9168-2975-E040-BB89AD434610

Brain and Central Nervous System Tumors NCT00887146 Pathology - North Central Cancer Treatment Group N0577 Baseline Blood Specimen Submission Form - 2745906v1.0 - North Central Cancer Treatment Group N0577 Baseline Blood Specimen Submission Form

- 1/8/15 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Header Module, Header
North Central Cancer Treatment Group N0577 Baseline Blood Specimen Submission Form Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C096CEC-6297-47DB-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

Brain and Central Nervous System Tumors NCT00887146 On-Study - North Central Cancer Treatment Group Baseline CD Submission Form - 2804462v1.0 - North Central Cancer Treatment Group Baseline CD Submission Form

- 1/8/15 - 1 form, 3 itemgroups, 18 items, 1 language
Itemgroups: Header Module, Header, Completed by VIEW Personnel:
North Central Cancer Treatment Group Baseline CD Submission Form Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C397187-1C79-4DCB-E044-0003BA3F9857

Brain and Central Nervous System Tumors NCT00887146 Treatment - North Central Cancer Treatment Group N0577 Concurrent Treatment Form - Baseline - 2745317v1.0 - North Central Cancer Treatment Group N0577 Concurrent Treatment Form - Baseline

- 1/8/15 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Header, Header
North Central Cancer Treatment Group N0577 Concurrent Treatment Form - Baseline Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C07E8C3-3333-293D-E044-0003BA3F9857

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Baseline

- 9/17/21 - 1 form, 19 itemgroups, 80 items, 1 language
Itemgroups: Administrative documentation, Assessment Date, Demography, Menopausal Status, Medical History, Symptoms, Study Start Date, Concomitant Agent, ECOG performance status, Personal history of malignant neoplasm, unspecified, Ovarian Carcinoma, Histology, Ovarian Carcinoma, Operative Surgical Procedures, Tumor stage, Tumor Markers, Physical Examination, Lower abdomen, X-Ray Computed Tomography, Plain x-ray, Electrocardiography, Questionnaires, Quality of life, Receptor
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

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