Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-30 @ 10:23 PM
Study NCT ID:
NCT03404661
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2018-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical and Biochemical Biomarkers in Early Pancreatic Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012633', 'term': 'Secretin'}], 'ancestors': [{'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '20cc of venous blood In case of pancreatic cyst, excess fluid above 2cc Excess tumor tissue including portions of cancer and normal tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methylated DNA markers as measured by mean percentage of total human DNA per pancreatic juice volume', 'timeFrame': 'one year', 'description': 'After pancreatic juice is collected, top 10 markers for pancreas cancer detection will be done from discovery and validation on tissue (AUC\\>.95) and from pilot pancreatic-juice testing (AUCs \\>0.9).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.", 'detailedDescription': 'Pancreatic juice collection is performed by intravenous injection of FDA approved synthetic human secretin (ChiRhoClin Inc., Burtonsville, MD) at a dose of 0.2 µg/kg will be administered while the endoscope is positioned in the second portion of the duodenum. From within the duodenum and without cannulation of the papilla of Vater, a 2.3-mm plastic aspiration catheter (Olympus, Tokyo, Japan) will be passed through the biopsy channel of the endoscope until visible on screen in the endoscopic monitor. Once active visible secretion via the papilla has begun, the first 10 ml of pancreatic juice will be collected via suctioning. This entire process from secretin injection to sample collection takes an average of 5 minutes. The sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are performed. The top 10 candidate markers from discovery and validation on tissue (AUCs \\>0.95) and from pilot pancreatic-juice testing (AUCs \\>0.9) will be evaluated in this study. Following extraction from an equivalent of 0.4 ml pancreatic juice, DNA will be bisulfite treated using optimized methods. Then, an assay of aberrant methylation on target genes will be conducted using the QuARTS technique. Results will be normalized to either a human DNA marker (eg, beta-actin) or a methylated DNA marker identified for normal pancreatic epithelium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pancreas cancer, controls at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms, and subjects with a familial history of pancreas cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer.\n* International normalized ratio (INR) less than 1.5\n* Platelet count \\>50,000\n\nExclusion Criteria:\n\n* Any medical condition that preclude the patient from having a therapeutic procedure regardless of the Endoscopic ultrasound (EUS) finding\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT03404661', 'briefTitle': 'Optical and Biochemical Biomarkers in Early Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study', 'orgStudyIdInfo': {'id': '17-005211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pancreas Cancer Subjects', 'description': 'Patients with pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.', 'interventionNames': ['Drug: Synthetic Human Secretin']}, {'label': 'Control Subjects', 'description': 'Controls will receive Synthetic Human Secretin during an endoscopy procedure. Controls are at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms.', 'interventionNames': ['Drug: Synthetic Human Secretin']}, {'label': 'Familial Pancreatic Cancer Subjects', 'description': 'Subjects who have a family history of pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure.', 'interventionNames': ['Drug: Synthetic Human Secretin']}], 'interventions': [{'name': 'Synthetic Human Secretin', 'type': 'DRUG', 'otherNames': ['ChiRhoStim'], 'description': 'Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.', 'armGroupLabels': ['Control Subjects', 'Familial Pancreatic Cancer Subjects', 'Pancreas Cancer Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Massimo Raimondo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Massimo Raimondo, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}