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CALGB 50901 Bone Marrow, Liver, & Spleen Evaluation Form

- 28-08-17 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Bone Marrow Evaluation, Liver and Spleen Evaluation
CALGB 50901 Bone Marrow, Liver, & Spleen Evaluation Form Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9F53BA1C-E73F-7A0D-E040-BB89AD43616B

Eligibility NCT00052936 NHL - Eligibility

- 22-12-14 - 1 Formulier, 2 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Disease characteristics, Patient characteristics and prior concurrent therapy
Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma DISEASE CHARACTERISTICS: - Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement) - CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed - B-cell NHL including the following: Stage III follicular lymphoma; Stage III follicular lymphoma and diffuse B-cell lymphoma; Lymphoblastic precursor B-cell lymphoma; Diffuse large cell B-cell lymphoma; Centroblastic; Immunoblastic; Plasmablastic; Anaplastic large cell; T-cell-rich B-cell lymphoma; Primary effusion lymphoma; Intravasal B-cell lymphoma; Primary mediastinal B-cell lymphoma; Mantle zone lymphoma, blastoid; Burkitt's lymphoma; Burkitt-like lymphoma; Aggressive marginal zone lymphoma (monocytoid); - T-cell NHL including the following: Lymphoblastic precursor T-cell lymphoma; Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS); Lennert's lymphoma; T-zone lymphoma; T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type; Anaplastic large cell lymphoma; ALK^+ - ALK^-; Extranodal NK/T-cell lymphoma, nasal type; Intestinal T/NK-cell lymphoma (with or without enteropathy); Hepatosplenic gamma-delta lymphoma; Subcutaneous panniculitis-like PTCL; Aggressive T/NK PTCL; Anaplastic large-cell NHL, NOS - Bone marrow involvement no more than 25% - No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract PATIENT CHARACTERISTICS: Age - 61 to 80 Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - WBC at least 2,500/mm^3; Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN); No active hepatitis infection Renal - Creatinine no greater than 2 times ULN Cardiovascular - No Canadian Cardiovascular Society class III or IV angina pectoris - No New York Heart Association class III or IV cardiac failure - Ejection fraction at least 50% - Fractional shortenings at least 25% by echocardiography or nuclear medicine examination Pulmonary - FEV1 at least 50% - Diffusion capacity at least 50% Other - No uncontrolled diabetes mellitus - No known hypersensitivity to any study medications - No other concurrent malignancy - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy Surgery - Not specified Other - Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study) - No other concurrent lymphoma therapy - No concurrent participation in another treatment study

dbGaP phs000559 PAGE: Epidemiologic Architecture for Genes Linked to Environment (EAGLE) - BioVU Cancer Project - Eligibility

- 12-12-22 - 5 Formulieren, 1 Itemgroep, 20 Data-elementen, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Dana Crawford, PhD, Vanderbilt University, Nashville, TN, USA MeSH: Neoplasms,Breast Neoplasms,Colorectal Neoplasms,Endometrial Neoplasms,Lung Neoplasms,Lymphoma, Non-Hodgkin,Ovarian Neoplasms,Melanoma,Prostatic Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000559 As part of Population Architecture using Genomics and Epidemiology PAGE study (Phase I), the Epidemiologic Architecture using Genomics and Epidemiology (EAGLE I) project accessed both epidemiologic- and clinic-based collections. The epidemiologic-based collection of EAGLE I included the National Health and Nutritional Examination Surveys (NHANES), ascertained between 1991-1994 (NHANES III), 1999-2002, and 2007-2008. NHANES is a population-based cross-sectional survey now conducted every year in the United States to assess the health status of Americans at the time of ascertainment and to assess trends over the years of survey. Genetic NHANES consists of 19,613 DNA samples linked to thousands of variables including demographics, health and lifestyle variables, physical examination variables, laboratory variables, and exposures. NHANES is diverse with almost one-half of the samples (46.4%) coming from self-reported Mexican Americans and non-Hispanic blacks. In contrast to NHANES, BioVU is a clinic-based collection of 150,000 DNA samples from Vanderbilt University Medical Center linked to de-identified electronic medical records (EMRs). Approximately 12% of BioVU's overall DNA sample collection is from African American, Hispanic, and Asian patients. The overall goals of PAGE I and EAGLE I were broad and several-fold:- Replicate genome-wide association study (GWAS)- identified variants in European Americans; - Identify population-specific and trans-population genotype-phenotype associations; - Identify genetic and environmental modifiers of these associations. NHANES is an excellent resource for the study of quantitative traits associated with common human diseases. However, given that the age range of NHANES spans childhood to late adulthood and not all diseases are surveyed, NHANES is less useful for the study of adult-onset diseases such as major cancers. Therefore, under American Recovery and Reinvestment Act (ARRA) funding, EAGLE as part of PAGE I defined eight major cancers sites for genetic analysis in BioVU, Vanderbilt's biorepository linked to de-identified EMRs. The eight major cancers defined for this study included melanoma, breast, ovarian, prostate, colorectal, lung, endometrial, and Non-Hodgkin's lymphoma (NHL). Cancer cases were defined using a combination of ICD-9 codes and tumor registry entries. Controls include BioVU participants without cancer and encompassing the age and gender distributions of cancer cases. Targeted genotyping of GWAS-identified variants for these diseases (124 SNPs) and ancestry informative markers (128 AIMs) was performed by the Center for Human Genetics Research Vanderbilt DNA Resources Core. After quality control, a total of 116 cancer-associated SNPs and 122 AIMs were available for downstream analyses.

pht003614.v1.p1

1 Itemgroep 2 Data-elementen

pht003615.v1.p1

1 Itemgroep 3 Data-elementen

pht003616.v1.p1

1 Itemgroep 58 Data-elementen

pht003617.v1.p1

1 Itemgroep 5 Data-elementen

Response - Non-Hodgkins Lymphoma - Baseline Disease Assessment Form - 2270115v3.0 - Non-Hodgkins Lymphoma - Baseline Disease Assessment Form

- 09-01-15 - 1 Formulier, 8 Itemgroepen, 75 Data-elementen, 1 Taal
Itemgroepen: CRF Header, Lymphoma: Form Administration, Lymphoma: Dominant Nodes, Lymphoma: Nondominant Nodes, Lymphoma: Measurable Hepatic/Splenic Nodules, Lymphoma: Non-Measurable Lesions, Lymphoma: Bone Marrow, Liver and Spleen Assessment, Lymphoma: Scanning/Imaging
Non-Hodgkin's Lymphoma - Baseline Disease Assessment Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D5EAA15D-A849-71DB-E034-0003BA12F5E7

Response - Non-Hodgkins Lymphoma - Follow-Up Disease Assessment Form - 2270621v3.0 - Non-Hodgkins Lymphoma - Follow-Up Disease Assessment Form

- 09-01-15 - 1 Formulier, 10 Itemgroepen, 88 Data-elementen, 1 Taal
Itemgroepen: CRF Header, Lymphoma: Form Administration, Lymphoma: Dominant Node Response, Lymphoma: Nondominant Lesion Response, Lymphoma: Measurable Hepatic/Splenic Nodule Response, Lymphoma: Non-Measurable Lesion Response, Lymphoma: New Lesions, Lymphoma: Bone Marrow, Liver and Spleen Response Assessment, Non-Hodgkin's Lymphoma: Biochemical and B Symptoms, Non-Hodgkin's Lymphoma: Response Assessment
Non-Hodgkin's Lymphoma - Follow-Up Disease Assessment Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D5EC0BF1-C6F3-750B-E034-0003BA12F5E7

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