Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 6:53 AM
Study NCT ID:
NCT01216267
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D002276', 'term': 'Carcinoid Tumor'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064747', 'term': 'Lansoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chromogranin A concentration serum', 'timeFrame': 'single time', 'description': 'For determination of normal CgA range, we will recruit 60 healthy subjects (30 female, 30 male), in whom a single plasma sample will be obtained for measurement of CgA B For determination of CgA in patients with carcinoid disease (active or inactaive), we wil recruit 200 patients with carcinoid disease from our local neuroendocinre oncology clinic.'}], 'secondaryOutcomes': [{'measure': 'Effect of PPI on chromogranin A concentration', 'timeFrame': '2 weeks', 'description': 'To determine the effect of PPI on chromogranin A concentration, we will recruit a subgroup of 12 healthy subjects who will take a bedtime lansoprazole 30 mg for 7 days. Fasting serum samples for CgA will be obtained at day 7 and 1, 2, 4, and 7 days after discontinuation of the PPI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chromogranin A', 'neuroendocrine', 'carcinoid', 'Proton Pump Inhibitor'], 'conditions': ['Neuroendocrine Carcinoma (Carcinoid)']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare several methods for measurement of Chromogranin A in their ability to serve as a marker for disease activity in patients with neuroendocrine tumors.\n\nFurther, in a subgroup, we will determine if taking a proton pump inhibitor affects Chromogranin A levels.', 'detailedDescription': 'Patient group: patients with neuroendocrine tumors (active or inactive) Healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients:\n\nInclusion Criteria:\n\n* having neuro-endocrine disease\n\nExclusion Criteria:\n\n* age below 18 or above 70 years\n* prostate cancer\n* kidney failure (estimated GF \\< 30 mL/Min)\n* heart failure\n* chronic atrophic gastritis\n* pregnancy\n\nHealthy subjects:\n\nInclusion Criteria:\n\n* healthy\n\nExclusion Criteria:\n\n* age below 18 or above 70 years\n* taking any chronic medication (except OCP)\n* prostate cancer\n* kidney failure (estimated GFR \\< 30 mL/min)\n* heart failure\n* pheochromocytoma\n* islet cell tumors\n* medullary thyroid cancer\n* essential hypertension\n* neurofibromatosis\n* use of proton pump inhibitors\n* chronic atrophic gastritis\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01216267', 'briefTitle': 'Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples', 'organization': {'class': 'OTHER', 'fullName': 'University of Western Ontario, Canada'}, 'officialTitle': 'Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples', 'orgStudyIdInfo': {'id': 'HSREB16279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lansoprazole', 'description': 'lansoprazole for 7 days', 'interventionNames': ['Drug: Lansoprazole']}], 'interventions': [{'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Prevacid'], 'description': 'lansoprazole 30 mg HS x 7 days', 'armGroupLabels': ['lansoprazole']}, {'name': 'lansoprazole', 'type': 'DRUG', 'otherNames': ['pravacid'], 'description': 'lanzoprazole 30 mg HS for 7 days', 'armGroupLabels': ['lansoprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "London Health Sciences Center and St. Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Stan Van Uum, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Stanislaus H. van Uum', 'investigatorAffiliation': 'University of Western Ontario, Canada'}}}}