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Type(s) of Cancer
Esophageal
Study Phase
Phase 2BPhase 3
Study Completion Date
2012-04
NCT00409188Uploaded 05-18-2020
Available for Download
PDS UID: Gastric_Multipl_1999_416
Enhancing the Analytic Capacity of Gastric_SanofiU_1999_143 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Gastric_SanofiU_1999_143, were matched with like cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset218
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/jtx7-ve58
CDISC StandardN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
ConditionsNon-small Cell Lung Cancer
Intervention TypeBiological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug(s)Drug: Single low dose cyclophosphamide
Drug: Placebo
Total Enrolled1513
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionTecemotide (L-BLP25) - Experimental
Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)24331154
24976972
34870327
25722382
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Romania
Russian Federation
Singapore
Slovakia
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLLinked Gastric_SanofiU_1999_143 Documentation.docx
CRFDataset Contents and Variable Crosswalk.xlsx
DATA DICTIONARYCODEBOOK_linked_gastric143.pdf
DATA SUMMARYProc Contents Data Dictionary Gastric_SanofiU_1999_143.pdf
DATA SUMMARYDescriptive_Stats_Linked_Gastric_SanofiU_1999_143.xlsx
DATA (COMPARATOR ARM)linked_gastric143.sas7bdat
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