Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00897520
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007124', 'term': 'Immunoenzyme Techniques'}], 'ancestors': [{'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum sample screening via high throughput protein profiling in patients undergoing therapy', 'timeFrame': '1 month'}, {'measure': 'Comparison of soluble factors', 'timeFrame': '1 month'}]}, 'conditionsModule': {'keywords': ['stage II melanoma', 'stage III melanoma', 'stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.\n\nPURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.', 'detailedDescription': "OBJECTIVES:\n\n* To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .\n* To compare soluble factors across all patients at each time point (baseline and during therapy).\n* To compare pre-therapy vs post-therapy serum samples from these patients.\n* To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.\n* To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.\n* To correlate statistically significant factors with S100 and autoimmunity in these patients.\n* To confirm the data obtained with the Luminex technology.\n\nOUTLINE: Patients are stratified according to survival (\\< 2 years vs \\> 5 years).\n\nBlood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples submitted for research from patients participating in E1694', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of high-risk melanoma\n* Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00897520', 'briefTitle': 'Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)', 'orgStudyIdInfo': {'id': 'CDR0000585297'}, 'secondaryIdInfos': [{'id': 'ECOG-E1694T1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant interferon alfa', 'type': 'BIOLOGICAL'}, {'name': 'proteomic profiling', 'type': 'GENETIC'}, {'name': 'immunoenzyme technique', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Monica Panelli, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ECOG-ACRIN Cancer Research Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}