Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02160366
Status:
UNKNOWN
Last Update Posted:
2020-01-10
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-09-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Biomarker Profiling to Treatment Outcome', 'timeFrame': '2 months', 'description': 'For correlating marker profiles with response to treatment, univariate and multivariate (multiple covariates) logistic regression used, with response status taken as outcome variable. Distributions of time-to-event outcomes estimated using Kaplan-Meier curves, and these distributions compared among groups using log rank test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Cancers', 'Molecular profiling', 'Biomarker data', 'Data analysis', 'Tumor marker'], 'conditions': ['Advanced Cancers']}, 'referencesModule': {'references': [{'pmid': '39413348', 'type': 'DERIVED', 'citation': 'Weitz J, Nishizaki D, Liau J, Patel J, Ng I, Sun S, Ramms D, Zou J, Wishart B, Rull J, Baumgartner J, Kelly K, White R, Veerapong J, Hosseini M, Patel H, Botta G, Gutkind JS, Tiriac H, Kato S, Lowy AM. Cyclin-Dependent Kinase 4/6 Inhibition as a Novel Therapy for Peritoneal Mucinous Carcinomatosis With GNAS Mutations. J Clin Oncol. 2025 Feb 20;43(6):705-715. doi: 10.1200/JCO.24.00511. Epub 2024 Oct 16.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this laboratory research study is to collect and analyze treatment, molecular profiling and biomarker data. The results of the data analysis will be used to better understand how to characterize tumors and identify therapies that may be tailored to individual patients and to identify and/or predict side effects that may occur and/or predict which therapies may be best for participants. Research may also be done on your existing tissue to identify new biomarkers.', 'detailedDescription': 'Molecular Profiling/Deep Sequencing:\n\nMolecular profiling is the classification of tissue based on the expression of certain genes within a tumor that might predict how the tumor responds to therapy. Deep sequencing is a more detailed type of molecular profile that allows for a more focused analysis of individual genes.\n\nBiomarker Data:\n\nA characteristic that is measured and evaluated as an indicator of normal biologic processes, disease processes or pharmacologic responses to a therapeutic intervention.\n\nStudy Participation:\n\nIf you agree to take part in this study, information from your medical record will be collected. The information that researchers will collect includes your medical history, chemotherapy schedule(s), as well as the results of any tests, procedures, and/or therapies you may have had. Your responses to the therapies, your side effects, and the results of any diagnostic tests performed during therapy will also be collected.\n\nResearchers want to learn if they could have better predicted your response to therapy using the information collected in this study and/or better predict side effects from your treatment.\n\nThe data collected from your medical record will be stored in a password-protected database at MD Anderson to be used in research related to this study for up to 10 years.\n\nIn addition, research studies on new biomarkers may be conducted on your previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.\n\nYour name, medical record number, and any other personal identifiable information collected from your medical record will be replaced with a code number. No identifying information will be directly linked to the data collected from your medical record. Only the doctor who is in charge of this study, and select members of their research staff, will have access to the code numbers and be able to link any of the data back to you.\n\nUse of Samples:\n\nBefore your banked tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your tissue samples from this bank, must first be approved by the IRB.\n\nYour tissue samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Other researchers using your samples will not be able to link this data to you.\n\nLength of Study:\n\nYour participation in this study will be over after either the data, blood, tumor tissue samples, and/or archived tumor samples are analyzed.\n\nThis is an investigational study.\n\nUp to 2000 participants will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to the Clinical Center for Targeted Therapy at UT MD Anderson Cancer Center in Houston, Texas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. All patients referred to the Clinical Center for Targeted Therapy are potentially eligible for recruitment.\n\nExclusion Criteria:\n\nn/a'}, 'identificationModule': {'nctId': 'NCT02160366', 'briefTitle': 'Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients', 'orgStudyIdInfo': {'id': 'LAB10-0441'}, 'secondaryIdInfos': [{'id': '3UL1RR024148-04S1', 'link': 'https://reporter.nih.gov/quickSearch/3UL1RR024148-04S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biomarker/Molecular Data Collection and Analyzation', 'description': 'Advanced cancer participants', 'interventionNames': ['Other: Biomarker Research']}], 'interventions': [{'name': 'Biomarker Research', 'type': 'OTHER', 'description': 'Research studies on new biomarkers conducted on previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.', 'armGroupLabels': ['Biomarker/Molecular Data Collection and Analyzation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Filip Janku, MD, PHD', 'role': 'CONTACT', 'email': 'fjanku@mdanderson.org', 'phone': '713-563-1930'}], 'overallOfficials': [{'name': 'Filip Janku, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}