Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT01388569
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2011-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
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': 'D005434', 'term': 'Flow Cytometry'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2011-07-02', 'studyFirstSubmitQcDate': '2011-07-02', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall and disease-free survival', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood from patients treated with sargramostim in the laboratory may help doctors learn more about the effects of sargramostim on cells. It may also help doctors understand how patients respond to treatment.\n\nPURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies with clinical outcome.\n\nSecondary\n\n* To correlate circulating anti-sargramostim (GM-CSF) antibody levels with clinical outcome.\n\nOUTLINE: Archived peripheral blood mononuclear cells and serum samples are analyzed for circulating myeloid-derived suppressor cells, Treg (CD3+/CD4+/CD25hi/FOXP3+) frequency, and anti-sargramostim (anti-GM-CSF) antibody levels by flow cytometry and anti-GM-CSF neutralizing antibody assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples from patient enrolled on E4697 from whom samples were submitted for research', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosed with melanoma\n\n * Stage IV disease\n * HLA-A2\\^+ and A2\\^+\n* Received sargramostim on clinical trial ECOG-4697\n* Specimens collected at baseline and either day 43 or day 85 (based on most consistent availability) from long-term survivors and patients with poor survival\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT01388569', 'briefTitle': 'Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Immune Counter-Regulation in Melanoma Patients Vaccinated With GM-CSF', 'orgStudyIdInfo': {'id': 'CDR0000703098'}, 'secondaryIdInfos': [{'id': 'ECOG-E4697T1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'flow cytometry', 'type': 'OTHER'}, {'name': 'immunologic technique', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lisa Butterfield, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}