Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-28 @ 8:33 AM
Study NCT ID:
NCT05376592
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D019282', 'term': 'Wasting Syndrome'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'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': 'Whole blood or buccal sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer cachexia (CC)', 'timeFrame': 'approx. 3 months', 'description': 'A binary variable will be determined for each subject indicating if they have developed CC within 3 months after diagnosis as defined as weight loss of at least 5%.'}], 'secondaryOutcomes': [{'measure': 'Cancer cachexia (CC)', 'timeFrame': 'approx. 3 months', 'description': 'A binary variable will be determined for each subject indicating if they have developed CC within 3 months after diagnosis as defined as weight loss of at least 10%.'}, {'measure': 'Sarcopenia', 'timeFrame': 'approx. 3 years', 'description': 'A binary variable will be determined for each subject indicating if they have developed sarcopenia at any point in time of or after diagnosis. Measurements of sarcopenia will be obtained via body composition analysis of available, routine CT and/or MRI imaging.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'approx. 3 years', 'description': 'Overall survival is defined as the duration of time from the date of diagnosis to the date of death from any cause.'}, {'measure': 'One-year survival', 'timeFrame': 'approx. 1 year', 'description': 'One-year survival will be determined as a binary variable for each subject indicating if the subject is alive one year after the date of diagnosis.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'approx. 3 years', 'description': 'Progression free survival is defined as the duration from date of diagnosis to first occurrence of either progressive disease or death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Cachexia', 'Wasting Syndrome', 'Pancreatic Cancer'], 'conditions': ['Pancreas Adenocarcinoma', 'Cachexia']}, 'descriptionModule': {'briefSummary': 'A major complication of pancreatic adenocarcinoma (PDAC) is cancer cachexia (CC) which is a complex syndrome characterized by skeletal muscle mass loss (with or without loss of fat mass) and progressive functional impairment not reversible by conventional nutritional support. It is estimated to occur in over 75% of patients with advanced PDAC, the highest incidence of all solid tumors, and contributes significantly to poor outcomes and mortality. Though there is overlap amongst the pathophysiologic studies evaluating CC in murine models of different tumor types, the high prevalence of CC within gastrointestinal (GI) malignancies and specifically PDAC suggest that dedicated studies evaluating polymorphisms in candidate genes specific to PDAC warrant further evaluation. The collection and analysis of specimens under this study will facilitate the identification and characterization of genomic polymorphisms associated with CC in PDAC patients. Subsequently, this data may help contribute towards diagnostic and therapeutic treatments that may improve patient outcomes.', 'detailedDescription': 'This pilot study consists of a cohort of 100 locally advanced unresectable or metastatic PDAC subjects with a prospective analysis of biomarkers that may be associated with CC, a major negative prognostic factor in outcomes.\n\nThe study protocol-directed assessments consist of four experimental measures (gene single nucleotide polymorphisms and available clinical information including weights, imaging review of sarcopenia, and select labs) used to determine factors that potentially contribute to CC in subjects with PDAC. Main confounding factors to be evaluated include stage of disease, receipt of anti-cancer therapies, and sites of metastatic disease.\n\nSpecimens collected from PDAC patients treated at Atrium Health Wake Forest Baptist Comprehensive Cancer Center may include blood or buccal swabs. Specimens may be collected during any standard of care clinic visit after screening and confirmation of eligibility.\n\nCollected and processed specimens will be stored for analysis at Atrium Health and analyzed in the Nutrition Research Institute (NRI). All specimen results will remain deidentified. Personal health information will be collected on study participants and linked to results of genomic analysis but will be deidentified prior to any data analysis and presentation at scientific conferences, sharing with non-Atrium Health investigators and for publications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with pancreatic adenocarcinoma will be will be approached for potential consent during a clinic visit at any participating Levine Cancer Institute location.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent and HIPAA authorization for release of personal health information by the subject in accordance with the practices of the Levine Cancer Institute and Atrium Health. NOTE: HIPAA authorization will be included in the informed consent.\n* Male or female patients age ≥ 18 years at the time of consent\n* Histological or cytological confirmation of pancreatic adenocarcinoma, with a diagnosis of locally advanced unresectable PDAC (LAPC) or metastatic pancreatic adenocarcinoma. LAPC is defined as per NCCN 16. Note: Subject can be enrolled at any time during their cancer course following histologic diagnosis.\n* Able to provide a blood or buccal sample.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05376592', 'briefTitle': 'Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Association of Genomic Polymorphisms With Cancer Cachexia in Subjects With Pancreatic Adenocarcinoma', 'orgStudyIdInfo': {'id': 'IRB00083490'}, 'secondaryIdInfos': [{'id': 'LCI-SUPP-PDAC-CC-001', 'type': 'OTHER', 'domain': 'Atrium Health'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'CynDavia McKoy', 'role': 'CONTACT', 'email': 'Cyndavia.Mckoy@advocatehealth.org', 'phone': '704-355-2000'}, {'name': 'Kunal Kadakia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ravi Paluri, MD', 'role': 'CONTACT', 'email': 'rpaluri@wakehealth.edu'}], 'facility': 'Atrium Health Wake Forest Baptist Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'CynDavia McKoy', 'role': 'CONTACT', 'email': 'Cyndavia.Mckoy@advocatehealth.org', 'phone': '704-355-2000'}], 'overallOfficials': [{'name': 'Kunal Kadakia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atrium Health Levine Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atrium Health Levine Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}