Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-22 @ 5:42 PM
Study NCT ID:
NCT06595160
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2024-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Shotgun Sequencing - Fecal Specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal Microbiome Alpha Diversity', 'timeFrame': 'Through study completion, an average of two years', 'description': 'Continuous variables will be presented as median with interquartile range and categorical variables will be presented as frequencies. Univariate logistic regression will be used to compare alpha diversity (mean inverse Simpson index) and relative abundance of operational taxonomic units up to species level in PDAC patients with and without major pathological response to neoadjuvant chemotherapy. Multivariable logistic regression analyses will be performed to identify significant factors associated with major pathological response after adjusting for age, gender, stage at presentation, and type of neoadjuvant chemotherapy and other factors based on univariate analyses or clinical significance.'}], 'secondaryOutcomes': [{'measure': 'Pathological Response Rate', 'timeFrame': 'Through study completion, an average of two years', 'description': 'Major pathological response rate in surgical specimen of operable PDAC patients after neoadjuvant chemotherapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Borderline Resectable Pancreatic Ductal Adenocarcinoma', 'Resectable Pancreatic Ductal Adenocarcinoma', 'Stage I Pancreatic Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': 'This study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate the association between pre-treatment diversity of the fecal microbiome and major pathological response to neoadjuvant chemotherapy in operable pancreatic ductal adenocarcinoma patients.\n\nII. Evaluate the association between pre-treatment HEI-2015 dietary score and major pathological response to neoadjuvant chemotherapy in pancreatic ductal adenocarcinoma patients.\n\nIII. Evaluate the association between pre-treatment HEI-2015 dietary score and diversity of the fecal microbiome in pancreatic ductal adenocarcinoma patients.\n\nOUTLINE: This is an observational study.\n\nPatients complete a dietary survey and undergo fecal sample collection on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with resectable or borderline resectable pancreatic ductal adenocarcinoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\* Age ≥ 18 years with signed informed consent form\n\n * Patients must have a histological diagnosis of PDAC\n * Resectable or borderline resectable PDAC on imaging\n\nExclusion Criteria:\n\n* \\* Patients with locally advanced and metastatic stage IV PDAC\n\n * Patients who have already received or completed neoadjuvant chemotherapy for PDAC\n * Patients with active malignancy receiving systemic therapy'}, 'identificationModule': {'nctId': 'NCT06595160', 'briefTitle': 'Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy in Pancreatic Ductal Adenocarcinoma Patients', 'orgStudyIdInfo': {'id': 'STUDY00007728'}, 'secondaryIdInfos': [{'id': 'NCI-2024-06743', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00007728', 'type': 'OTHER_GRANT', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'EU6255-24', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'P30CA138292', 'link': 'https://reporter.nih.gov/quickSearch/P30CA138292', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients complete a dietary survey and undergo fecal sample collection on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mihir M. Shah', 'role': 'CONTACT', 'email': 'mihir.m.shah@emory.edu', 'phone': '404-778-3307'}, {'name': 'Mihir M. Shah', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University Hospital/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Mihir M. Shah, MD, FACS, FSSO', 'role': 'CONTACT', 'email': 'mihir.m.shah@emory.edu', 'phone': '404-778-3307'}], 'overallOfficials': [{'name': 'Mihir M Shah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Hospital/Winship Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mihir M. Shah, MD, FACS, FSSO', 'investigatorAffiliation': 'Emory University'}}}}