Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-30 @ 6:15 AM
Study NCT ID:
NCT03172403
Status:
TERMINATED
Last Update Posted:
2022-08-25
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001827', 'term': 'Body Height'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D049628', 'term': 'Body Size'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000067029', 'term': 'Physical Appearance, Body'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006128', 'term': 'Growth'}, {'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'The study was stopped prematurely by decision of the sponsor due to lack of inclusion.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-29', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between skeletal muscle and degree myostatin', 'timeFrame': 'Day 1', 'description': 'Evaluate correlation between skeletal muscle force/index and degree myostatin. Skeletal muscle force/index will be determinated by skeletal muscle force/index results.\n\nDegree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.'}], 'secondaryOutcomes': [{'measure': 'Correlation between skeletal muscle force and index before resection surgery', 'timeFrame': 'Baseline from 7 months', 'description': 'Evaluate Correlation between skeletal muscle force and index before resection surgery to estimate the extent of cachexia-induced muscle dysfunction by results tests.'}, {'measure': 'Correlation between level of myostatin muscular expression and degree myostatin', 'timeFrame': 'Month 2', 'description': 'Evaluate correlation between level of myostatin muscular expression and degree myostatin.\n\nLevel of myostatin muscular expression will be determinated by muscle biopsy. Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.'}, {'measure': 'Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery', 'timeFrame': 'Month 2', 'description': 'Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.'}, {'measure': 'Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery', 'timeFrame': 'Month 4', 'description': 'Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.'}, {'measure': 'Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery', 'timeFrame': 'Month 7', 'description': 'Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.'}, {'measure': 'Analysis level of myostatin muscular expression and blood samples results', 'timeFrame': 'Month 2', 'description': 'Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cachexia', 'Cancer of Digestive System', 'Myostatin', 'Skeletal muscle'], 'conditions': ['Cancer of Digestive System']}, 'descriptionModule': {'briefSummary': 'Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men aged 40-80.\n* Diagnosis for cancer of digestive system requiring surgery with neoadjuvant treatment or not.\n* Signature of consent\n* Affiliate or beneficiary of social security\n\nExclusion Criteria:\n\n* Administration of corticosteroids.\n* Thyroid disease treated.\n* Severe chronic pathology during treatment (neuro-muscular pathologies, renal insufficiency requiring dialysis, COPD under continuous oxygen therapy).\n* Psychological, familial, social or geographical conditions that could affect the participation of the subject throughout the duration of the protocol.\n* BMI\\> 30 due to the difficulty of interpretation of BMI variations in obese patients'}, 'identificationModule': {'nctId': 'NCT03172403', 'acronym': 'MYOCAC', 'briefTitle': 'Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)', 'orgStudyIdInfo': {'id': '1708054'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2017-A01233-50'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with digestive cancer requiring resection surgery', 'description': 'Patients with cancer of digestive system requiring resection surgery will be included. They will have measure of height and weight, blood samples, skeletal muscle force, skeletal muscle index and muscle biopsy.\n\nV1: Inclusion will be effectuated at the time of anaesthetic consultation V2: The day before and day of resection surgery about 1 month after V3: Follow-up at 1 month V4: Follow-up at 3 months V6: Follow-up at 6 months', 'interventionNames': ['Diagnostic Test: Height and weight', 'Diagnostic Test: Blood samples', 'Diagnostic Test: Skeletal muscle force', 'Diagnostic Test: Skeletal muscle index', 'Diagnostic Test: Muscle biopsy']}], 'interventions': [{'name': 'Height and weight', 'type': 'DIAGNOSTIC_TEST', 'description': 'Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1)', 'armGroupLabels': ['Patients with digestive cancer requiring resection surgery']}, {'name': 'Blood samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples will be collected for measuring myostatin on blood at the time of anaesthetic consultation, the day before resection surgery, follow-ups at 1, 3 and 6 months. (V1, V2, V3, V4, V6)', 'armGroupLabels': ['Patients with digestive cancer requiring resection surgery']}, {'name': 'Skeletal muscle force', 'type': 'DIAGNOSTIC_TEST', 'description': 'Skeletal muscle force will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)', 'armGroupLabels': ['Patients with digestive cancer requiring resection surgery']}, {'name': 'Skeletal muscle index', 'type': 'DIAGNOSTIC_TEST', 'description': 'Skeletal muscle index will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)', 'armGroupLabels': ['Patients with digestive cancer requiring resection surgery']}, {'name': 'Muscle biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)', 'armGroupLabels': ['Patients with digestive cancer requiring resection surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Karine ABBOUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}