Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT03998202
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2019-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood obtained for DNA extraction'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Chemotherapy Toxicities (Grade 3 - 5)', 'timeFrame': 'Up to 6 months (after initiation of chemotherapy)', 'description': 'Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '1 year', 'description': 'Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Myopenia', 'Sarcopenia', 'Chemotherapy', 'Geriatric-Oncology'], 'conditions': ['Colorectal Cancer', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.', 'detailedDescription': 'This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed metastatic CRC or metastatic recurrence of CRC \\>= 3 months (12 weeks) from diagnosis at 60 years or older.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \\>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC.\n* Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable.\n* Estimated life expectancy \\>= 6 months.\n* Patients must be able to comprehend English or Spanish (for questionnaire completion).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- \\> 10%) body weight change in the previous 12 months are eligible for this study.\n\nExclusion Criteria:\n\n* Patients enrolled on hospice.\n* Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \\>= 3 months (12 weeks) prior to this disease disease recurrence and treatment).\n* Patients may not be receiving any other investigational agents.\n* No untreated brain metastases. Patients with treated brain metastases are eligible.\n* Patients on or planned to undergo radiation therapy in near future.'}, 'identificationModule': {'nctId': 'NCT03998202', 'acronym': 'M&M', 'briefTitle': 'Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study', 'orgStudyIdInfo': {'id': 'IRB00058811'}, 'secondaryIdInfos': [{'id': 'NCI-2019-02514', 'type': 'REGISTRY', 'domain': 'NCI Trial Identifier [CTRP]'}, {'id': 'WF-1806', 'type': 'REGISTRY', 'domain': 'LPO ID'}, {'id': 'IRB00058811', 'type': 'OTHER', 'domain': 'WF eIRB ID'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults 60-74 years'}, {'label': 'Adults >= 75 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19967', 'city': 'Millville', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'research@Beebehealthcare.org', 'phone': '302-291-6730'}, {'name': 'Gregory A. Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beebe South Coastal Health Campus', 'geoPoint': {'lat': 38.54956, 'lon': -75.12324}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'lbarone@christianacare.org', 'phone': '302-623-4450'}, {'name': 'Gregory A. Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helen F Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'lbarone@christianacare.org', 'phone': '302-623-4450'}, {'name': 'Gregory A. Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Oncology Hematology Consultants PA', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19971', 'city': 'Rehoboth Beach', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'research@Beebehealthcare.org', 'phone': '302-291-6730'}, {'name': 'Gregory A. Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beebe Health Campus', 'geoPoint': {'lat': 38.72095, 'lon': -75.07601}}, {'zip': '19801', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'lbarone@christianacare.org', 'phone': '302-623-4450'}, {'name': 'Gregory Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christiana Care Health System-Wilmington Hospital', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '202-444-2223'}, {'name': 'Marcus S. Noel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'cdean@iacthealth.com', 'phone': '706-478-7968'}, {'name': 'Andrew Pippas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John B Amos Cancer Center', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '61704', 'city': 'Bloomington', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare-Bloomington', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '61520', 'city': 'Canton', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare-Canton', 'geoPoint': {'lat': 40.55809, 'lon': -90.03512}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '312-864-5204'}, {'name': 'Thomas E. Lad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John H Stroger Jr Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61832', 'city': 'Danville', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Research@Carle.com', 'phone': '800-446-5532'}, {'name': 'Suparna Mantha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carle at The Riverfront', 'geoPoint': {'lat': 40.12448, 'lon': -87.63002}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'morganthaler@dmhhs.org', 'phone': '217-876-4762'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Care Specialists of Illinois - Decatur', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '62401', 'city': 'Effingham', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'morganthaler.jodi@mhsil.com', 'phone': '217-876-4762'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Crossroads Cancer Center', 'geoPoint': {'lat': 39.12004, 'lon': -88.54338}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare-Galesburg', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61938', 'city': 'Mattoon', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Research@carle.com', 'phone': '800-446-5532'}, {'name': 'Suparna Mantha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carle Physician Group - Mattoon/Charleston', 'geoPoint': {'lat': 39.48309, 'lon': -88.37283}}, {'zip': '62864', 'city': 'Mount Vernon', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '618-242-4600'}, {'name': 'Jay W. Carlson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SSM Health Good Samaritan', 'geoPoint': {'lat': 38.31727, 'lon': -88.90312}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Research@Carle.com', 'phone': '800-446-5532'}, {'name': 'Suparna Mantha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carle BroMenn Medical Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Research@Carle.com', 'phone': '800-446-5532'}, {'name': 'Suparna Mantha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carle Cancer Institute Normal', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '62269', 'city': "O'Fallon", 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'morganthaler.jodi@mhsil.com', 'phone': '217-876-4762'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cancer Care Center of O'Fallon", 'geoPoint': {'lat': 38.59227, 'lon': -89.91121}}, {'zip': '61350', 'city': 'Ottawa', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare-Ottawa Clinic', 'geoPoint': {'lat': 41.34559, 'lon': -88.84258}}, {'zip': '61554', 'city': 'Pekin', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare-Pekin', 'geoPoint': {'lat': 40.56754, 'lon': -89.64066}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare-Peoria', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61354', 'city': 'Peru', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare-Peru', 'geoPoint': {'lat': 41.32753, 'lon': -89.12897}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '217-545-7929'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '800-444-7541'}, {'name': 'Bryan A. Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Springfield Clinic', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Research@carle.com', 'phone': '800-446-5532'}, {'name': 'Suparna Mantha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '61571', 'city': 'Washington', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'andersonj@illinoiscancercare.com', 'phone': '309-243-3605'}, {'name': 'Bryan Faller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois CancerCare - Washington', 'geoPoint': {'lat': 40.70365, 'lon': -89.40731}}, {'zip': '50023', 'city': 'Ankeny', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '515-282-2921'}, {'name': 'Richard Deming', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Iowa - Ankeny', 'geoPoint': {'lat': 41.72971, 'lon': -93.60577}}, {'zip': '51401', 'city': 'Carroll', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'sbenson@iora.org', 'phone': '515-689-7658'}, {'name': 'Seema Harichand-Herdt', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Anthony Regional Hospital', 'geoPoint': {'lat': 42.06582, 'lon': -94.86693}}, {'zip': '52402', 'city': 'Cedar Rapids', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '319-297-2900'}, {'name': 'Bhaarat Jenigiri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Physicians' Clinic of Iowa PC", 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '319-363-2690'}, {'name': 'Deborah W. 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