Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT06098404
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood and Stool will be coll'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of fecal microbiome using molecular methods at baseline', 'timeFrame': 'Baseline', 'description': "Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline"}, {'measure': 'Characterization of fecal microbiome using molecular methods at 6 months', 'timeFrame': '6 months', 'description': "Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR after 6 months of standard of care treatment."}], 'secondaryOutcomes': [{'measure': 'Cognitive Function as measured by Montreal Cognitive Assessment at baseline', 'timeFrame': 'Baseline', 'description': 'The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA-BLIND v8.1 will be used in this study as it can be administered in person as well as over the telephone. The MoCA-BLIND consists of 9 questions with the following subcategories: memory, attention, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. The MoCA will be administered by a certified tester at enrollment. Scores range from 0 to 22, higher score being a better outcome.'}, {'measure': 'Cognitive Function as measured by Montreal Cognitive Assessment at 6 months', 'timeFrame': '6 months', 'description': 'The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA-BLIND v8.2 will be used in this study as it can be administered in person as well as over the telephone. The MoCA-BLIND consists of 9 questions with the following subcategories: memory, attention, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. The MoCA will be administered by a certified tester at enrollment. Scores range from 0 to 22, higher score being a better outcome. The MoCA will be performed after 6 months of standard of care treatment.'}, {'measure': 'Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline', 'timeFrame': 'Baseline', 'description': 'The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition.\n\nThere are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.'}, {'measure': 'Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months', 'timeFrame': '6 months', 'description': 'The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A\\&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition.\n\nThere are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition. The FACS will be performed after 6 months of standard of care treatment.'}, {'measure': 'Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline', 'timeFrame': 'Baseline', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).'}, {'measure': 'Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months.', 'timeFrame': '6 months', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome). The GSRS will be performed after 6 months of standard of care treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'Fatigue', 'Cognition'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.', 'detailedDescription': 'Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients. CRCI is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. Although CRCI is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. Using identical methods to monitor CRCI symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms.\n\nSpecific Aims\n\nSpecific Aim 1: Characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies.\n\nSpecific Aim 2: Assess fatigue in cancer patients and determine associations with composition of the gut microbiome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be selected from community cancer clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Current diagnosis of cancer.\n2. Ages 18 and over.\n3. Has access to a device (smart phone, computer, tablet) with internet access.\n4. Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Females who are pregnant or lactating.\n2. Other medical conditions or medications deemed exclusionary by the study investigators.'}, 'identificationModule': {'nctId': 'NCT06098404', 'briefTitle': 'Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study', 'orgStudyIdInfo': {'id': '23-0289'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Patients', 'description': 'Patients diagnosed with cancer undergoing standard of care treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kate Randolph, BS', 'role': 'CONTACT', 'email': 'kmrandol@utmb.edu', 'phone': '409-223-7891'}, {'name': 'Melinda Sheffield-Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'centralContacts': [{'name': 'Kate Randolph, BS', 'role': 'CONTACT', 'email': 'kmrandol@utmb.edu', 'phone': '409-223-7891'}, {'name': 'Kristen McGovern, PhD', 'role': 'CONTACT', 'email': 'kamcgove@utmb.edu', 'phone': '409-772-8126'}], 'overallOfficials': [{'name': 'Melinda Sheffield-Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}