{ "FullStudy":{ "Rank":217700, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517971", "OrgStudyIdInfo":{ "OrgStudyId":"CALGB-150807" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"CALGB-150807" },{ "SecondaryId":"CDR0000720368", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NCI Physician Data Query" } ] }, "Organization":{ "OrgFullName":"Alliance for Clinical Trials in Oncology", "OrgClass":"OTHER" }, "BriefTitle":"Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer", "OfficialTitle":"Validation of Molecular Prognostic Tests in NSCLC" }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2100", "PrimaryCompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 22, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 24, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Alliance for Clinical Trials in Oncology", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Cancer Institute (NCI)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.", "DetailedDescription":"PRIMARY OBJECTIVES:\n\nI. To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (RNA)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.\n\nSECONDARY OBJECTIVES:\n\nI. To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.\n\nII. To determine the effects on test accuracy of the histological subtype (adenocarcinoma [AC] vs squamous cell [SQA]) for each of the stage specific prognostic classifiers.\n\nIII. To determine the relevant statistical features, including accuracy of predicting overall survival, cancer specific survival, and disease free survival at 3 and 5 years, for each of the prognostic classifiers validated.\n\nIV. To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to determine whether these can reliably predict good outcome among stage II NSCLC patients.\n\nOUTLINE:\n\nRNA extracted from archived tumor tissue samples are analyzed for whole-genome expression by Affymetrix microarrays (Gene Profiling Array cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Lung Cancer" ] }, "KeywordList":{ "Keyword":[ "stage IA non-small cell lung cancer", "stage IB non-small cell lung cancer", "adenocarcinoma of the lung", "squamous cell lung cancer" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Retrospective" ] } }, "BioSpec":{ "BioSpecRetention":"Samples With DNA", "BioSpecDescription":"Tissue samples" }, "EnrollmentInfo":{ "EnrollmentCount":"1060", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Ancillary-correlative (whole-genome expression)", "ArmGroupDescription":"RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Gene Profiling Array cGMP U133 P2 and RT-PCR.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: laboratory biomarker analysis" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"laboratory biomarker analysis", "InterventionDescription":"Correlative studies", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ancillary-correlative (whole-genome expression)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Recurrence", "PrimaryOutcomeTimeFrame":"up to 36 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Cancer specific survival", "SecondaryOutcomeTimeFrame":"Up to 36 months" },{ "SecondaryOutcomeMeasure":"Disease-free survival", "SecondaryOutcomeTimeFrame":"up to 36 months" },{ "SecondaryOutcomeMeasure":"Overall survival", "SecondaryOutcomeTimeFrame":"up to 36 months" },{ "SecondaryOutcomeMeasure":"Probability of death due to other causes", "SecondaryOutcomeTimeFrame":"up to 36 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nRegistration to CALGB-140202\nThe subject population to be studied in this protocol includes patients selected from CALGB-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the CALGB does not require that a separate consent form be signed for this study\nAll samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly\nTumor specimens need to have 40% tumor content to be included", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Patients diagnosed with NSCLC enrolled on the Cancer and Leukemia Group B (CALGB) 140202", "SamplingMethod":"Probability Sample" }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Raphael Bueno, MD", "CentralContactRole":"Contact", "CentralContactPhone":"617-732-8148" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Raphael Bueno, MD", "OverallOfficialAffiliation":"Brigham and Women's Cancer Center", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Brigham and Women's Hospital", "LocationStatus":"Recruiting", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02115", "LocationCountry":"United States", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Raphael Bueno, MD", "LocationContactRole":"Contact", "LocationContactPhone":"617-732-8533" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008175", "ConditionMeshTerm":"Lung Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012142", "ConditionAncestorTerm":"Respiratory Tract Neoplasms" },{ "ConditionAncestorId":"D000013899", "ConditionAncestorTerm":"Thoracic Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9755", "ConditionBrowseLeafName":"Lung Neoplasms", "ConditionBrowseLeafAsFound":"Lung Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4128", "ConditionBrowseLeafName":"Carcinoma, Non-Small-Cell Lung", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2166", "ConditionBrowseLeafName":"Adenocarcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M1687", "ConditionBrowseLeafName":"Adenocarcinoma of Lung", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13562", "ConditionBrowseLeafName":"Respiratory Tract Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15241", "ConditionBrowseLeafName":"Thoracic Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T3533", "ConditionBrowseLeafName":"Lung Adenocarcinoma", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }