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Eligibility Neoplasms NCT00606788

- 01-09-16 - 1 Formulier, 1 Itemgroep, 11 Data-elementen, 1 Taal
Itemgroep: Inclusion Criteria
Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning; ODM derived from: https://clinicaltrials.gov/show/NCT00606788

Cancer (clinical) DSS Metadata Online Registry (METeOR)

- 03-08-16 - 1 Formulier, 16 Itemgroepen, 65 Data-elementen, 1 Taal
Itemgroepen: Chemotherapy for cancer cluster, Hormone therapy for cancer cluster, Immunotherapy for cancer cluster, Radiotherapy for cancer cluster, Surgery for cancer cluster, Systemic therapy procedure for cancer cluster, Cancer staging, Cancer treatment, Date, Establishment, Healthcare provider, Patient, Person (address), Person (name), Person with cancer, Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Cancer (clinical) DSS The purpose of the Cancer (clinical) data set specification (C(C)DSS) is to define data standards for the national collection of clinical cancer data so that data collected is consistent and reliable. Collection of this data set specification is not mandated but it is recommended as best practice if clinical cancer data are to be collected. It will facilitate more consistent data collection while enabling individual treatment centres or health service areas to develop data extraction and collection processes and policies that are appropriate for their service settings. Mandatory reporting regulations have enabled population-based cancer registries in Australia to collect standard information on all incident cases of cancer apart from non-melanoma skin cancers, from which incidence, mortality and overall survival have been determined and trends monitored. The Cancer (clinical) data set specification provides a framework for the collection of more detailed and comprehensive clinical data such as stage of cancer at diagnosis, other prognostic characteristics, cancer treatment and patient outcomes. The Cancer (clinical) data set specification will support prospective data collection from the time a person with cancer symptoms is referred or first presents to a hospital or specialist through the entire duration of their illness. The majority of data items in the Cancer (clinical) data set specification are applicable to most solid tumours while many are also relevant to the haematopoietic malignancies such as leukaemia and lymphoma. Data set specifications for specialist tumour streams are also under development and these will contain supplementary data elements that will capture the special features of specific cancer types. The definitions used in this data set specification are designed to capture the provision of cancer care on a day-to-day level. They relate to the cancer care pathway and the need to optimise care by correctly diagnosing, evaluating and managing patients with cancer. In addition, end-points and patterns of care can be monitored to understand both the appropriateness and effectiveness of cancer care. The data elements specified provide a framework for: • promoting the delivery of evidence-based care to patients with cancer • facilitating the ongoing improvement in the quality and safety of cancer management in treatment settings • improving the epidemiological and public health understanding of cancer • informing treatment guidelines and professional education • guiding resource planning and the evaluation of cancer control activities They will facilitate the aggregation of data across different treatment centres. The underlying long-term goal is to provide data support to improve outcomes for patients by increasing the quality and length of life. For example, a comparison of the actual management of patients with best practice guidelines may identify shortfalls in treatment and limitations in access to treatment modalities for some patients. The working group formed under the stewardship of Cancer Australia was diverse and included representation from the following organisations: Cancer Australia, University of Sydney-Department of Gynaecological Oncology, Westmead Institute for Cancer Research, Cancer Council Victoria, Royal Brisbane & Women’s Hospital, National Breast and Ovarian Cancer Centre, The Royal Women's Hospital, Queensland Health, Ministry of Health, NSW Health, TROG Cancer Research, and the Cancer Institute NSW. To ensure the broad acceptance of the data set specification, the proposed list of data items was circulated to members of Cancer Australia’s National Cancer Data Strategy Advisory Group, a multidisciplinary group with a broad spectrum of epidemiological knowledge and expertise, and the inter-governmental Strategic Forum, comprising clinicians and senior health department officials from the Australian Government and from each state and territory government, and with strong community representation. The working group also sought consultation from cancer registry data managers, clinical leaders, pathologists, medical oncologists and radiation oncologists to achieve consensus when required. The Cancer (clinical) data set specification is intended to only describe data collected in relation to the initial course of cancer treatment. The initial course of treatment includes all treatments administered to the patient from diagnosis and before disease progression or recurrence. © Australian Institute of Health and Welfare 2015 Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Eligibility Advanced Cancers NCT01444716

- 09-05-16 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT01444716

Cancer Treatments Protocol PhenX Toolkit

- 26-04-16 - 1 Formulier, 1 Itemgroep, 18 Data-elementen, 1 Taal
Itemgroep: PhenX - cancer treatment protocol
These questions start by asking if the respondent has had cancer. For respondents who have had cancer, detailed follow-up questions ask about the type of cancer treatment, including surgery, chemotherapy, radiation, and hormone therapy. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

On-Study Form Bladder Cancer NCT00014534 CALGB-90104

- 21-08-15 - 1 Formulier, 3 Itemgroepen, 61 Data-elementen, 1 Taal
Itemgroepen: Muscle Invasive Bladder Disease: Prior Treatment Affecting the Bladder, Prior Therapy Date, CCRR MODULE
On-Study Form Bladder Cancer NCT00014534 CALGB-90104 NCT00014534 NCI Cooperative Group On-Study Form-Revised (CALGB-90104) Combination Chemotherapy in Treating Patients With Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE1B6E9C-942E-7181-E034-0003BA12F5E7

S0337 Cover Sheet for Patient-Completed Questionnaires NCT00445601

- 05-07-15 - 1 Formulier, 4 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Header, Patient response to questionnaire, Form completed by, Comments
S0337 Cover Sheet for Patient-Completed Questionnaires NCT00445601 Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FE26037B-446B-4AC6-E034-0003BA3F9857

SOUTHWEST ONCOLOGY GROUP BASELINE TUMOR ASSESSMENT FORM

- 12-06-15 - 1 Formulier, 4 Itemgroepen, 20 Data-elementen, 1 Taal
Itemgroepen: Header, Target lesion status, Diagnostic Test, COMMENTS
SOUTHWEST ONCOLOGY GROUP BASELINE TUMOR ASSESSMENT FORM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F4422C8B-0C70-49D1-E034-0003BA3F9857

Southwest Oncology Group Registration Form (25757) NCT00020709

- 03-06-15 - 1 Formulier, 3 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: SWOG clinical trial administrative data, Stratification Factors, Notes
Southwest Oncology Group Registration Form (25757) NCT00020709 S0023: Combination Chemo Plus RT With or Without Gefitinib in Treating Patients With Unresectable Stage III NSCLC Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9CA62D43-4FA4-361C-E034-080020C9C0E0

Radiation Therapy Oncology Group Phase III Lung Prophylactic Cranial RT Neurocognitive Evaluation Summary Form NCT00048997

- 03-06-15 - 1 Formulier, 3 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Header Module, Neurocognitive Evaluation, CCRR MODULE
Radiation Therapy Oncology Group Phase III Lung Prophylactic Cranial RT Neurocognitive Evaluation Summary Form NCT00048997 Radiation Therapy in Preventing CNS Metastases in Patients With Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A5472EED-0175-07F2-E034-080020C9C0E0

Radiation Therapy Oncology Group Phase III Lung Prophylactic Cranial RT MMSE NCT00048997

- 03-06-15 - 1 Formulier, 3 Itemgroepen, 35 Data-elementen, 1 Taal
Itemgroepen: Header Module, Neurocognitive Evaluation, CCRR MODULE
Radiation Therapy Oncology Group Phase III Lung Prophylactic Cranial RT MMSE NCT00048997 Radiation Therapy in Preventing CNS Metastases in Patients With Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A5D1AB4A-E01B-3595-E034-080020C9C0E0

ACNS1123 Eligibility - FP.0000

- 02-06-15 - 1 Formulier, 11 Itemgroepen, 42 Data-elementen, 1 Taal
Itemgroepen: STRATIFICATION, TUMOR LOCATION Elig - Block 1, TUMOR LOCATION Elig - Block 2, INCLUSION CRITERIA - NGGCT STRATUM 1, INCLUSION CRITERIA - Germinoma STRATUM 2, ORGAN FUNCTION REQUIREMENT - Bone Marrow Function, ORGAN FUNCTION REQUIREMENT - Renal Function, ORGAN FUNCTION REQUIREMENT - Liver Function, CENTRAL NERVOUS SYSTEM FUNCTION, EXCLUSION CRITERIA, REGULATORY
ACNS1123 Eligibility Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

ECOG 4599 Toxicity Form

- 28-05-15 - 1 Formulier, 1 Itemgroep, 27 Data-elementen, 1 Taal
Itemgroep: ECOG clinical trial administrative data
ECOG 4599 Toxicity Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A16E9046-8508-5FB4-E034-080020C9C0E0

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