Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT06375434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Feces；Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Five-year survival rate', 'timeFrame': '5 year'}], 'primaryOutcomes': [{'measure': 'Diameter of tumor', 'timeFrame': '30 days', 'description': 'The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated'}], 'secondaryOutcomes': [{'measure': 'Change in Gut Microbiota Composition', 'timeFrame': '30 days', 'description': 'Change in gut microbiota composition, including alterations in bacterial taxa, diversity, and abundance, between rectal cancer patients sensitive to radiotherapy and a control group of patients insensitive to radiotherapy.'}, {'measure': 'Change in Plasma metabolites', 'timeFrame': '30 days', 'description': "Metabolomics sequencing, including profiling of metabolites and their differences, was performed on patients' plasma before radiotherapy."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy.', 'detailedDescription': 'The study is expected to enroll 100 patients with locally advanced rectal cancer, including 50 patients in the radiotherapy-sensitive group and 50 in the radiotherapy-resistant group. Each participant will provide stool and blood samples before treatment for subsequent metagenomic and metabolomic sequencing analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "This study will enroll 100 patients with locally advanced rectal cancer, aged 18-75, scheduled for neoadjuvant treatment. Participants will be divided into two groups of 50: one sensitive to radiotherapy and the other resistant. Each will provide stool and blood samples for metagenomic and metabolomic sequencing to investigate the gut microbiome's role in radiotherapy sensitivity. This will aid in identifying predictive biomarkers for personalized treatment strategies.", 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with late-stage rectal cancer (stages IIIB to IV), including those with postoperative recurrence re-staging or those intending to receive neoadjuvant treatment,\n2. Pathological type is adenocarcinoma,\n3. Have measurable lesions before radiotherapy or chemotherapy,\n4. Age between 18 and 75 years,\n5. A WHO Performance Status (PS) score of 0 to 2, capable of tolerating radiotherapy or chemotherapy,\n6. An expected survival period of 6 months or more;\n7. Able to understand the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with severe complications or other malignant diseases.\n2. Known severe allergic reactions to components of radiotherapy or chemotherapy.\n3. Significant cardiac, hepatic, renal, or other vital organ dysfunction.\n4. Pregnant or breastfeeding women.\n5. Patients unable to comply with study requirements or affected by psychiatric or psychological diseases.\n6. Participation in other clinical trials recently that could affect the assessment of this study's results."}, 'identificationModule': {'nctId': 'NCT06375434', 'acronym': 'GMRSC-LARC', 'briefTitle': 'Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Xinjiang Medical University'}, 'officialTitle': 'The Mechanistic Study on the Influence of Gut Microbiota on Radiotherapy Sensitivity in Patients With Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': '20240101-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiosensitive group', 'interventionNames': ['Other: No intervention']}, {'label': 'The radiotherapy-insensitive group', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Radiosensitive group', 'The radiotherapy-insensitive group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jing-kun Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jing-kun Liu', 'investigatorAffiliation': 'Xinjiang Medical University'}}}}