Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 12:44 PM
Study NCT ID:
NCT00897793
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D018304', 'term': 'Esthesioneuroblastoma, Olfactory'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020431', 'term': 'Olfactory Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018962', 'term': 'Phlebotomy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D014964', 'term': 'X-Ray Therapy'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'venous blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-10', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TGF-beta levels', 'timeFrame': 'day 1 prior to treatment, 24-72 hours after 1st treatment, weekly at treatment (optional) and at completion of treatment', 'description': 'TGF-beta is a protein that can be detected in the blood.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent squamous cell carcinoma of the hypopharynx', 'stage I squamous cell carcinoma of the hypopharynx', 'stage II squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the larynx', 'recurrent verrucous carcinoma of the larynx', 'stage I squamous cell carcinoma of the larynx', 'stage I verrucous carcinoma of the larynx', 'stage II squamous cell carcinoma of the larynx', 'stage II verrucous carcinoma of the larynx', 'stage III squamous cell carcinoma of the larynx', 'stage III verrucous carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx', 'stage IV verrucous carcinoma of the larynx', 'recurrent adenoid cystic carcinoma of the oral cavity', 'recurrent mucoepidermoid carcinoma of the oral cavity', 'recurrent verrucous carcinoma of the oral cavity', 'stage I adenoid cystic carcinoma of the oral cavity', 'stage I mucoepidermoid carcinoma of the oral cavity', 'stage I verrucous carcinoma of the oral cavity', 'stage II adenoid cystic carcinoma of the oral cavity', 'stage II mucoepidermoid carcinoma of the oral cavity', 'stage II verrucous carcinoma of the oral cavity', 'stage III adenoid cystic carcinoma of the oral cavity', 'stage III mucoepidermoid carcinoma of the oral cavity', 'stage III verrucous carcinoma of the oral cavity', 'stage IV adenoid cystic carcinoma of the oral cavity', 'stage IV mucoepidermoid carcinoma of the oral cavity', 'stage IV verrucous carcinoma of the oral cavity', 'stage I squamous cell carcinoma of the lip and oral cavity', 'stage II squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'recurrent basal cell carcinoma of the lip', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'stage I basal cell carcinoma of the lip', 'stage II basal cell carcinoma of the lip', 'stage III basal cell carcinoma of the lip', 'stage IV basal cell carcinoma of the lip', 'metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'recurrent metastatic squamous neck cancer with occult primary', 'untreated metastatic squamous neck cancer with occult primary', 'recurrent lymphoepithelioma of the nasopharynx', 'recurrent squamous cell carcinoma of the nasopharynx', 'stage I lymphoepithelioma of the nasopharynx', 'stage I squamous cell carcinoma of the nasopharynx', 'stage II lymphoepithelioma of the nasopharynx', 'stage II squamous cell carcinoma of the nasopharynx', 'stage III lymphoepithelioma of the nasopharynx', 'stage III squamous cell carcinoma of the nasopharynx', 'stage IV lymphoepithelioma of the nasopharynx', 'stage IV squamous cell carcinoma of the nasopharynx', 'recurrent lymphoepithelioma of the oropharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'stage I lymphoepithelioma of the oropharynx', 'stage I squamous cell carcinoma of the oropharynx', 'stage II lymphoepithelioma of the oropharynx', 'stage II squamous cell carcinoma of the oropharynx', 'stage III lymphoepithelioma of the oropharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage IV lymphoepithelioma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'recurrent inverted papilloma of the paranasal sinus and nasal cavity', 'recurrent midline lethal granuloma of the paranasal sinus and nasal cavity', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'stage I inverted papilloma of the paranasal sinus and nasal cavity', 'stage I midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage I squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'stage II inverted papilloma of the paranasal sinus and nasal cavity', 'stage II midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage II squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'stage III inverted papilloma of the paranasal sinus and nasal cavity', 'stage III midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage III squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'stage IV inverted papilloma of the paranasal sinus and nasal cavity', 'stage IV midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity', 'high-grade salivary gland mucoepidermoid carcinoma', 'low-grade salivary gland mucoepidermoid carcinoma', 'recurrent salivary gland cancer', 'salivary gland acinic cell tumor', 'salivary gland adenocarcinoma', 'salivary gland adenoid cystic carcinoma', 'salivary gland anaplastic carcinoma', 'salivary gland malignant mixed cell type tumor', 'salivary gland poorly differentiated carcinoma', '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', 'limited stage small cell lung cancer', 'recurrent non-small cell lung cancer', 'recurrent small cell lung cancer', 'stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'extensive stage small cell lung cancer', 'male breast cancer', 'recurrent breast cancer', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer', 'recurrent colon cancer', 'stage I colon cancer', 'stage II colon cancer', 'stage III colon cancer', 'stage IV colon cancer', 'recurrent rectal cancer', 'stage I rectal cancer', 'stage II rectal cancer', 'stage III rectal cancer', 'stage IV rectal cancer', 'recurrent prostate cancer', 'stage I prostate cancer', 'stage II prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer'], 'conditions': ['Breast Cancer', 'Colorectal Cancer', 'Head and Neck Cancer', 'Lung Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may help doctors predict how patients will respond to treatment with radiation therapy.\n\nPURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial cancers who are undergoing radiation therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancers.\n\nOUTLINE: Patients undergo blood sample collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Patients will also be asked for a weekly blood sample, but this is optional. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People who have epithelial cancers and who will undergo radiation therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Known diagnosis of an epithelial cancer, including any of the following:\n\n * Head and neck\n * Lung\n * Breast\n * Colorectal\n * Prostate\n* Radiotherapy must be a component of planned treatment therapy\n\nPATIENT CHARACTERISTICS:\n\n* No serious medical or psychiatric illnesses which would prevent informed consent'}, 'identificationModule': {'nctId': 'NCT00897793', 'briefTitle': 'Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'A Pilot Study of TGF-beta as a Potential Target for Prevention of Radiation-Induced Injury', 'orgStudyIdInfo': {'id': 'VICC RAD 0576'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-RAD-0576'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with epithelial cancers', 'description': 'Patients with head and neck cancer, and lung, breast, colorectal, and prostate cancers who are to undergo radiation therapy', 'interventionNames': ['Procedure: venipuncture', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'venipuncture', 'type': 'PROCEDURE', 'otherNames': ['blood sample collection'], 'description': 'Venipuncture for blood samples. Samples will be tested for TGF-beta.', 'armGroupLabels': ['patients with epithelial cancers']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'otherNames': ['x-ray treatment'], 'description': "Radiation treatments vary according to type of cancer and by patient per doctors' recommendation", 'armGroupLabels': ['patients with epithelial cancers']}]}, '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': 'A. Bapsi Chakravarthy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'A Bapsi Chakravarthy, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}