Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00899769
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D013058', 'term': 'Mass Spectrometry'}], 'ancestors': [{'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in serum protein profiles and differences in the number of peptide matches'}, {'measure': 'Protein levels and the largest difference in peptide matches in sera'}]}, 'conditionsModule': {'keywords': ['metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'recurrent squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'recurrent squamous cell carcinoma of the nasopharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage I squamous cell carcinoma of the hypopharynx', 'stage I squamous cell carcinoma of the larynx', 'stage I squamous cell carcinoma of the lip and oral cavity', 'stage I squamous cell carcinoma of the nasopharynx', 'stage I squamous cell carcinoma of the oropharynx', 'stage I squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage II squamous cell carcinoma of the hypopharynx', 'stage II squamous cell carcinoma of the larynx', 'stage II squamous cell carcinoma of the lip and oral cavity', 'stage II squamous cell carcinoma of the nasopharynx', 'stage II squamous cell carcinoma of the oropharynx', 'stage II squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage III squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the larynx', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the nasopharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the nasopharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity', 'untreated metastatic squamous neck cancer with occult primary', 'recurrent metastatic squamous neck cancer with occult primary', 'recurrent salivary gland cancer', 'salivary gland squamous cell carcinoma', 'stage I salivary gland cancer', 'stage II salivary gland cancer', 'stage III salivary gland cancer', 'stage IV salivary gland cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with cancer and from healthy volunteers may help doctors identify and learn more about biomarkers related to cancer.\n\nPURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer and in healthy volunteers.', 'detailedDescription': 'OBJECTIVES:\n\n* Correlate the differences in serum protein profiles with the differences in the number of peptide matches in patients with squamous cell carcinoma of the head and neck and in healthy volunteers.\n* Correlate protein levels with the largest difference in peptide matches in sera in these participants.\n\nOUTLINE: This is a prospective study.\n\nParticipants undergo blood, tissue, and saliva collection for biological studies. Samples are analyzed for albumin-bound and non-albumin-bound proteins or IgG via liquid chromatography and tandem mass spectrometry (LC-MS-MS), ELISA, proteomic profiling, and protein expression.\n\nPROJECTED ACCRUAL: A total of 50 patients and 50 healthy volunteers will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets one of the following criteria:\n\n * Diagnosis of squamous cell carcinoma of the head and neck\n * Healthy volunteer matched by sex, race, birth decade, or smoking status (e.g., current smoker, former smoker, or nonsmoker)\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00899769', 'briefTitle': 'Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Serum Biomarkers for Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'CDR0000546781'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-HN-0530'}, {'id': 'VU-VICC-IRB-050230'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'proteomic profiling', 'type': 'GENETIC'}, {'name': 'immunoenzyme technique', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'liquid chromatography', 'type': 'OTHER'}, {'name': 'mass spectrometry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center - Cool Springs', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center at Franklin', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Wendell G. Yarbrough, MD, FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}