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  2. 2. Routine Documentation
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Follow-Up - Follow-Up Oncology

- 11/2/15 - 1 form, 5 itemgroups, 16 items, 19 languages
Itemgroups: Identity, Diagnosis, Therapy, Study, Follow-up
Follow Up Dokumentation zur automatischen Berechnung von Kaplan-Meier Kurven.

register Finish Cancer Registry cancer - register

- 3/15/21 - 1 form, 6 itemgroups, 49 items, 2 languages
Itemgroups: CancerRegistry, Previous cancer, Current Neoplasm, Treatment, surgery, radiotherapy
Data set from the Finish cancer registry, with friendly permission (http://www.cancer.fi/syoparekisteri/en/registration/forms-and-instructions/)

dbGaP phs000428 Health and Retirement Study (HRS) - pht005036.v1.p2

- 1/29/25 - 6 forms, 1 itemgroup, 4 items, 1 language
Itemgroup: pht005036
Principal Investigator: David Weir, PhD, University of Michigan, Ann Arbor, MI, USA MeSH: Aging,Neoplasms,Arthritis,Lung Diseases, Obstructive,Dementia,Heart Diseases,Heart Failure,Hypertension,Myocardial Infarction,Diabetes Mellitus,Hypercholesterolemia,Obesity,Body Weight,Mobility Limitation,Pain,Cholesterol,Hemoglobin A, Glycosylated,C-Reactive Protein,Cystatin C,Depression,Alcohol Drinking,Smoking,Personality,Life Style,Cognition,Demography,Ethnic Groups,Health Status,Population Groups,Housing,Independent Living,Socioeconomic Factors,Career Mobility,Educational Status,Employment,Family Characteristics,Income,Occupations,Poverty,Social Change,Social Class,Social Conditions,Risk Factors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000428 *Introduction to V2: *This data release comprises data from the V1 release combined with approximately 3,000 additional samples, collected during the HRS 2010 field period. The 2010 data include samples from a random half of the new cohort enrolled in 2010 along with a significant expansion of the minority sample. *Description:* The University of Michigan Health and Retirement Study (HRS) is a longitudinal panel study that surveys a representative sample of approximately 20,000 people in America over the age of 50 every two years. Supported by the National Institute on Aging (NIA U01AG009740) and the Social Security Administration, the HRS explores the changes in labor force participation and the health transitions that individuals undergo toward the end of their work lives and in the years that follow. The study collects information about income, work, assets, pension plans, health insurance, disability, physical health and functioning, cognitive functioning, and health care expenditures. Through its unique and in-depth interviews, the HRS provides an invaluable and growing body of multidisciplinary data that researchers can use to address important questions about the challenges and opportunities of aging. Because of its innovation and importance, the HRS has become the model and hub for a growing network of harmonized longitudinal aging studies around the world. *Origins of the HRS.* As the population ages it is increasingly important to obtain reliable data about aging and topics that are relevant to a range of policy issues in aging. To address this need, the National Institutes on Aging (NIA) established a cooperative agreement with the University of Michigan Institute for Social Research to collect such data. The HRS launched data collection in 1992 and has re-interviewed the original sample of respondents every two years since then. By adding new cohorts and refreshing the sample, the HRS has grown to become the largest, most representative longitudinal panel study of Americans 50 years and older. *HRS Study Design.* The target population for the original HRS cohort includes all adults in the contiguous United States born during the years 1931-1941 who reside in households, with a 2:1 oversample of African-American and Hispanic populations. The original sample is refreshed with new birth cohorts (51-56 years of age) every six years. The sample has been expanded over the years to include a broader range of birth cohorts as well. The target population for the AHEAD survey consists of United States household residents who were born in 1923 or earlier. Children of the Depression (CODA) recruits households born 1924-1930, War Babies 1942-47, Early Boomers 1948-53, and Mid-Boomers 1954-59. Data collection includes a mixed mode design combining in-person, telephone, mail, and Internet. For consenting respondents, HRS data are linked at the individual level to administrative records from Social Security and Medicare claims. *Genetic Research in the HRS.* The HRS has genotyped 2.5 million single nucleotide polymorphisms (SNPs) on respondents using Illumina's Human Omni2.5-Quad (Omni2.5) BeadChip. The genotyping was performed by the NIH Center for Inherited Disease Research (CIDR). Saliva was collected on half of the HRS sample each wave starting in 2006. In 2006, saliva was collected using a mouthwash collection method. From 2008 onward, the data collection method switched to the Oragene kit. Saliva completion rates were 83% in 2006, 84% in 2008, and 80% in 2010 among new cohort enrollees. HRS Phenotypic data. Phenotypic data are available on a variety of dimensions. Health measures include physical/psychological self-report, various health conditions, disabilities, cognitive performance, health behaviors (smoking, drinking, exercise), physical performance and anthropomorphic measures, and biomarkers (HbA1c, Total Cholesterol, HDL, CRP, Cystatin-C). Data are also available on health services including utilization, insurance and out-of-pocket spending with linkage to Medicare records. Economic measures include employment status/history, earnings, disability, retirement, type of work, income by source, wealth by asset type, capital gains/debt, consumption, linkage to pensions, Social Security earnings/benefit histories. There is also extensive information on family structure, proximity, transfers to/from of money, time, social and psychological characteristics, as well as a wide range of demographics. Performance on a cognitive test combining immediate and delayed word recall was selected as an example trait for the dbGaP data release. In the immediate word recall task the interviewer reads a list of 10 nouns to the respondent and asks the respondent to recall as many words as possible from the list in any order. After approximately five minutes of asking other survey questions, the respondent is asked to recall the nouns previously presented as part of the immediate recall task. The total recall score is the sum of the correct answers to these two tasks, with a range of 0 to 20. Researchers who wish to link to other HRS measures not in dbGaP will be able to apply for access from HRS. A separate Data Use Agreement (DUA) will be required for linkage to the HRS data. See the HRS website (http://hrsonline.isr.umich.edu/gwas) for details.

Eligibility

1 itemgroup 6 items

pht002612.v2.p2

1 itemgroup 4 items

pht002613.v2.p2

1 itemgroup 5 items

pht002614.v2.p2

1 itemgroup 7 items

pht005037.v1.p2

1 itemgroup 5 items

dbGaP phs000694 Clinical Cancer Sequencing - pht003754.v3.p2

- 1/29/25 - 4 forms, 1 itemgroup, 2 items, 1 language
Itemgroup: pht003754
Principal Investigator: Levi Garraway, Dana Farber Cancer Institute, Boston, MA, USA MeSH: Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000694 Translating whole exome sequencing (WES) for prospective clinical use may impact the care of cancer patients; however, multiple innovations are necessary for clinical implementation. These include: (1) rapid and robust WES from formalin-fixed paraffin embedded (FFPE) tumor tissue, (2) analytical output similar to data from frozen samples, and (3) clinical interpretation of WES data for prospective use. In this study, we describe a prospective clinical WES platform for archival FFPE tumor samples. The platform employs computational methods for effective clinical analysis and interpretation of WES data. When applied retrospectively to 511 exomes, the interpretative framework revealed a "long tail" of somatic alterations in clinically important genes. Prospective application of this approach identified clinically relevant alterations in 15/16 patients. Overall, this methodology may inform the widespread implementation of precision cancer medicine.

pht003755.v3.p2

1 itemgroup 3 items

pht003757.v3.p2

1 itemgroup 3 items

pht003756.v3.p2

1 itemgroup 2 items

EORTC QLQ_C30 - EORTC QLQ_C30 MS University Hospital Muenster (UKM)

- 11/7/17 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: General information
Used as Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: EORTC QLQ-C30 MS. Copyright: 1995 EORTC Quality of Life Group. All rights reserved. Version 3.0 German description: EORTC QLQ-C30 (version 3.0) Wir sind an einigen Angaben interessiert, die Sie und Ihre Gesundheit betreffen. Bitte beantworten Sie die folgenden Fragen selbst, indem Sie die Zahl ankreuzen, die am besten auf Sie zutrifft. Es gibt keine "richtigen" oder "falschen" Antworten. Ihre Angaben werden streng vertraulich behandelt.

dbGaP phs000942 Use of WGS for Diagnosis and Discovery in the Cancer Genetics Clinic - Eligibility

- 11/27/24 - 5 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: Theodora S. Ross, MD, PhD, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA, and Department of Cancer Genetics, UT Southwestern Medical Center, Dallas, TX, USA MeSH: Neoplasms,Breast Neoplasms,Ovarian Neoplasms,Peritoneal Neoplasms,Skin Neoplasms,Esophageal Neoplasms,Thyroid Neoplasms,Urinary Bladder Neoplasms,Endometrial Neoplasms,Fallopian Tube Neoplasms,Melanoma,Testicular Neoplasms,Bile Duct Neoplasms,Lung Neoplasms,Colonic Neoplasms,Adrenocortical Carcinoma,Carcinoma, Renal Cell,Colonic Polyps,Adenomatous Polyposis Coli,Lymphoma, Large B-Cell, Diffuse,Pheochromocytoma,Paraganglioma,Leiomyoma,Hemangioblastoma,Hyperparathyroidism,Pancreatic Neoplasms,Vulvar Neoplasms,Brain Neoplasms,Liver Neoplasms,Kidney Neoplasms,Prostatic Neoplasms,Glioblastoma,Oncocytoma, renal https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000942 Despite the potential of whole-genome sequencing (WGS) to improve patient diagnosis and care, the empirical value of WGS in the cancer genetics clinic is unknown. We performed WGS on members of two cohorts of cancer genetics patients: those with BRCA1/2 mutations (n = 176) and those without (n = 82). Initial analysis of potentially pathogenic variants (PPVs, defined as nonsynonymous variants with allele frequency 1% in ESP6500) in 163 clinically-relevant genes suggested that WGS will provide useful clinical results. This is despite the fact that a majority of PPVs were novel missense variants likely to be classified as variants of unknown significance (VUS). Furthermore, previously reported pathogenic missense variants did not always associate with their predicted diseases in our patients. This suggests that the clinical use of WGS will require large-scale efforts to consolidate WGS and patient data to improve accuracy of interpretation of rare variants. While loss-of-function (LoF) variants represented only a small fraction of PPVs, WGS identified additional cancer risk LoF PPVs in patients with known BRCA1/2 mutations and led to cancer risk diagnoses in 21% of non-BRCA cancer genetics patients after expanding our analysis to 3209 ClinVar genes. These data illustrate how WGS can be used to improve our ability to discover patients' cancer genetic risks. "Reprinted from doi:10.1016/j.ebiom.2014.12.003, with permission from EBioMedicine."

pht004834.v1.p1

1 itemgroup 5 items

pht004835.v1.p1

1 itemgroup 5 items

pht004836.v1.p1

1 itemgroup 16 items

pht004837.v1.p1

1 itemgroup 5 items

dbGaP phs000827 N.C. Clinical Genomic Evaluation by NextGen Exome Sequencing (NCGENES) - Eligibility

- 3/4/24 - 5 forms, 1 itemgroup, 8 items, 1 language
Itemgroup: IG.elig
Principal Investigator: James P. Evans, MD, PhD, University of North Carolina, Chapel Hill, NC, USA MeSH: Genetic Diseases, Inborn,Neoplasms,Adenomatous Polyposis Coli,Microcephaly,Aortic Aneurysm, Thoracic,Peripheral Nervous System Diseases,Cardiomyopathies,Leukodystrophy, Globoid Cell,Seizures,Mitochondria,Inflammation,Autoimmune Diseases,Progeria,Retina,Muscular Diseases,Rhabdomyolysis,Arrhythmias, Cardiac,Osteochondrodysplasias,Intellectual disability,Autistic Disorder,Neuromuscular Diseases,Paraplegia,Central Nervous System Diseases,Cholestasis,Anemia,Genetic Testing https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000827 North Carolina Clinical Genomic Evaluation by Next-generation Exome Sequencing This study is part of a larger consortium project investigating the validity and best use of next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care. Participants are patients who were either seen in the UNC Cancer and Adult Genetics Clinic or referred to the study by their physician. They will be approached by their physician or a genetic counselor for recruitment. Once enrolled, a clinical geneticist or genetic counselor will obtain consent and collect blood samples to be analyzed using WES. Results may include information related to a diagnosis and incidental information. Medically actionable incidental findings will be CLIA-certified and returned to participants in a routine genetic counseling session, along with diagnostic findings. Eligible adult participants will be randomized to have the opportunity to choose to get certain types of non-medically actionable incidental findings, as well. Their decisions will be investigated, as will psychosocial and behavioral responses to sequencing and receiving sequencing information. This is a longitudinal, mixed methods study (i.e., multiple assessments pre- and post-return of results, with both quantitative and qualitative methods used to gather data). Because only the quantitative component of the study uses randomization, only measures and procedures associated with that component are included here. The third study release includes data of additional n=189 subjects.

pht004472.v3.p1

1 itemgroup 7 items

pht004469.v3.p1

1 itemgroup 5 items

pht004470.v3.p1

1 itemgroup 5 items

pht004471.v3.p1

1 itemgroup 7 items

dbGaP phs001043 GWAS of Breast Events with Adjuvant Aromatase Inhibitors - pht005313.v1.p1

- 8/7/23 - 5 forms, 1 itemgroup, 2 items, 1 language
Itemgroup: pht005313
Principal Investigator: James N. Ingle, M.D., Mayo Clinic, Rochester, MN, USA MeSH: Neoplasm,Breast Neoplasms,Neoplasm Metastasis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001043 *Source of patients*:The source of the patients for this genome-wide case-control study was MA.27, which was conducted as a multi-cooperative group effort under the auspices of the NCI Breast Cancer Intergroup of North America. The NCIC Clinical Trials Group (CTG) serves as the coordinating group, with participation by the NCI-sponsored North Central Cancer Treatment Group, Eastern Cooperative Oncology Group (ECOG), Southwest Oncology Group, and Cancer and Leukemia Group B (CALGB). MA.27 involved postmenopausal women with histologically confirmed and completely resected invasive breast cancer with surgical margins clear of invasive carcinoma in the following TMN categories (AJCC Version 6): pT1, pT2, pT3; pNx, pN0, pN1, pN2, pN3 (only when the sole basis is presence of 10 or more involved axillary nodes); MO. The primary tumor must have been estrogen receptor (ER) and/or progesterone receptor positive. Patients were stratified by lymph node status at diagnosis, prior adjuvant chemotherapy, and trastuzumab use and were randomized to 5 years of adjuvant therapy with anastrozole or exemestane. The trial was activated on May 26, 2003, and reached its accrual objectives on July 31, 2008, after the randomization of 6827 North American patients, with the majority (79%) providing DNA and consent for genetic testing. Non-North American patients were also entered by the International Breast Cancer Study Group but they did not contribute DNA. From 2003 to December 21, 2004, patients also underwent a second randomization to celecoxib 400 mg twice daily or placebo but, after the entry of 1,622 patients, this treatment was discontinued because of reports of increased cardiovascular risk associated with celecoxib. The final results of this study have been published, see Goss et al., 2013 (23358971). The patients in this analysis came from three cohorts: Cohort 1 consisted of 870 patients genotyped on the Illumina Human610-Quad BeadChip studied in a GWAS with the phenotype of musculoskeletal adverse event, see Ingle et al., 2010 (20876420), Cohort 2 consisted of 882 patients genotyped on the Illumina OmniExpress platform studied in a GWAS with the phenotype of fragility fractures, see Liu et al., 2014 (25148458), and the remaining 2913 patients were genotyped with the Illumina OmniExpressExome platform.

pht005314.v1.p1

1 itemgroup 3 items

pht005315.v1.p1

1 itemgroup 28 items

pht005316.v1.p1

1 itemgroup 6 items

Eligibility

1 itemgroup 3 items

dbGaP phs001052 Multi-Dimensional ClinOmics for Precision Therapy - Eligibility

- 7/9/23 - 5 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: MeSH: Neoplasms,Sarcoma,Sarcoma, Ewing,Rhabdomyosarcoma,Wilms Tumor,Desmoplastic Small Round Cell Tumor,Carcinoma, Transitional Cell,Rhabdoid Tumor,Sarcoma, Synovial,Neuroblastoma,Neuroendocrine tumors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001052 The Center for Cancer Research (CCR), of the intramural NCI undertook a multidimensional clinical genomics study of children and adolescent young adults with relapsed and refractory cancers who were enrolled on other therapeutic trials to determine the feasibility of a genome guided precision therapy protocol in these patients.

pht005466.v2.p1

1 itemgroup 2 items

pht005467.v2.p1

1 itemgroup 3 items

pht005468.v2.p1

1 itemgroup 3 items

pht005469.v2.p1

1 itemgroup 6 items

dbGaP phs001066 DNA and RNA Sequence of an Acute Lymphoblastic Leukemia - pht005280.v1.p1

- 6/23/23 - 4 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht005280
Principal Investigator: Richard K. Wilson, PhD, McDonnell Genome Institute, Washington University School of Medicine, St. Louis, MO, USA MeSH: Neoplasms,Leukemia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001066 We used massively parallel sequencing technology to profile the genomic DNA and RNA of tumor cells (leukemic bone marrow) and normal cells (skin biopsy) obtained from a single patient with Acute Lymphoblastic Leukemia (ALL), referred to throughout this study as 'ALL1'. Included in this study are samples obtained from a primary tumor, first relapse, second relapse and several intermediate timepoints. We identified somatic mutations present in each tumor by analysis of whole genome (WGS) and exome sequence data. Single nucleotide variants (SNVs) and small insertions and deletions were identified in both the exome and WGS data. Large copy number variations (CNVs) and structural variants (SVs) were identified in the WGS data. A custom capture reagent was designed to target most variants and used to generate deep validation sequence data. The expression status of all somatic variants was assessed by RNA-seq. The RNA-seq data was also used for gene expression analysis and gene fusion detection.

pht005281.v1.p1

1 itemgroup 3 items

pht005282.v1.p1

1 itemgroup 2 items

pht005283.v1.p1

1 itemgroup 5 items

dbGaP phs001075 Sequencing to Guide Cancer Care (CanSeq) - pht006108.v1.p1

- 6/23/23 - 4 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht006108
Principal Investigator: Levi Garraway, Dana Farber Cancer Institute, Boston, MA, USA MeSH: Neoplasms,Colonic Neoplasms,Lung Neoplasms,Adenocarcinoma of lung https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001075 The overall goal of the CanSeq U01 project is to study the impact of whole-exome sequencing (WES) on the clinical care of cancer patients and oncology provider practices. The aims of Project 1 are to implement and establish the feasibility of germline and somatic WES in patients with advanced solid tumors (lung and colon); to develop a framework for interpreting and reporting for exome sequencing data; to determine the proportion of patients with "actionable items" compared to existing technologies; and to report on the percentage of patients in whom unique WES findings led to a clinical action. The aims of Project 2 are to implement a production-scale platform for WES from archival (FFPE) material; to identify biologically relevant somatic and germline alterations existing in tumor/normal DNA from individual patients; to produce an evidence-based list of clinically "actionable" genetic alterations; and to develop inferential models that predict the utility of tumor genomic data within the larger clinical context. The goals of Project 3 are to describe the impact of information derived through WES on cancer patients; to test the hypothesis that patients will want to receive information about all potentially informative somatic and germline variants; to study patients' understanding of disclosed genomic information; and to describe the experiences of oncology providers as they implement WES into cancer care delivery.

pht006109.v1.p1

1 itemgroup 3 items

pht006111.v1.p1

1 itemgroup 3 items

pht006110.v1.p1

1 itemgroup 2 items

dbGaP phs001112 Chromosome X Mosaicism Methylation Study - pht005470.v1.p1

- 6/19/23 - 5 forms, 1 itemgroup, 2 items, 1 language
Itemgroup: pht005470
Principal Investigator: Stephen Chanock, National Cancer Institute, National Health Institute, Bethesda, MD, USA MeSH: Neoplasm https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001112 This study investigates methylation patterns in promoter regions on the X chromosomes of females with X chromosome mosaicism in an effort to phase mosaic events to either the active or inactive X chromosome.

pht005471.v1.p1

1 itemgroup 3 items

pht005473.v1.p1

1 itemgroup 5 items

pht005472.v1.p1

1 itemgroup 4 items

Eligibility

1 itemgroup 1 item

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