Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-04-09 @ 12:14 AM
Study NCT ID:
NCT00994669
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2009-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2009-10-13', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.', 'timeFrame': 'Post-dosing 12 to 22 hours', 'description': 'Assess the slope of the terminal D-3MH/3MH decay curve for the post-dosing time period as calculated using plasma or urine samples and after a meat-containing or meat-free test meal.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cachexia']}, 'descriptionModule': {'briefSummary': 'The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples. In addition, the investigators hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal muscle proteins to a greater extent than a non-meat-containing meal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample of healthy males and male lung cancer patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* 30-85 years\n* Body Mass Index (BMI) \\<30 kg/m2\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Glomerular filtration rate less than 60 mL/min/1.73 m2\n* History of recurrent gastrointestinal bleeding\n* Unable or unwilling to provide informed consent\n* Ongoing anti-coagulant therapy'}, 'identificationModule': {'nctId': 'NCT00994669', 'briefTitle': 'Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients', 'orgStudyIdInfo': {'id': '09-150B'}, 'secondaryIdInfos': [{'id': '5R01CA127971', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA127971', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy control male'}, {'label': 'lung cancer male'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Melinda Sheffield-Moore, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}