Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-10 @ 2:28 PM
Study NCT ID:
NCT02456051
Status:
TERMINATED
Last Update Posted:
2017-11-20
First Post:
2015-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D021441', 'term': 'Carcinoma, Pancreatic Ductal'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'enrollment was terminated because of the poor recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2015-05-25', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pancreatic cancer diagnosis', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic Carcinoma', 'New-Onset Diabetes', 'Adrenomedullin', 'Early Diagnosis', 'Biological Markers'], 'conditions': ['Diabetes Mellitus, Adult-Onset', 'Diabetes Complications', 'Carcinoma, Pancreatic Ductal', 'Pancreatic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '22895395', 'type': 'BACKGROUND', 'citation': 'Poruk KE, Firpo MA, Adler DG, Mulvihill SJ. Screening for pancreatic cancer: why, how, and who? Ann Surg. 2013 Jan;257(1):17-26. doi: 10.1097/SLA.0b013e31825ffbfb.'}, {'pmid': '18061176', 'type': 'BACKGROUND', 'citation': 'Chari ST, Leibson CL, Rabe KG, Timmons LJ, Ransom J, de Andrade M, Petersen GM. Pancreatic cancer-associated diabetes mellitus: prevalence and temporal association with diagnosis of cancer. Gastroenterology. 2008 Jan;134(1):95-101. doi: 10.1053/j.gastro.2007.10.040. Epub 2007 Oct 26.'}, {'pmid': '20981102', 'type': 'BACKGROUND', 'citation': 'Yachida S, Jones S, Bozic I, Antal T, Leary R, Fu B, Kamiyama M, Hruban RH, Eshleman JR, Nowak MA, Velculescu VE, Kinzler KW, Vogelstein B, Iacobuzio-Donahue CA. Distant metastasis occurs late during the genetic evolution of pancreatic cancer. Nature. 2010 Oct 28;467(7319):1114-7. doi: 10.1038/nature09515.'}, {'pmid': '15886696', 'type': 'BACKGROUND', 'citation': 'Huxley R, Ansary-Moghaddam A, Berrington de Gonzalez A, Barzi F, Woodward M. Type-II diabetes and pancreatic cancer: a meta-analysis of 36 studies. Br J Cancer. 2005 Jun 6;92(11):2076-83. doi: 10.1038/sj.bjc.6602619.'}, {'pmid': '21458985', 'type': 'BACKGROUND', 'citation': 'Ben Q, Xu M, Ning X, Liu J, Hong S, Huang W, Zhang H, Li Z. Diabetes mellitus and risk of pancreatic cancer: A meta-analysis of cohort studies. Eur J Cancer. 2011 Sep;47(13):1928-37. doi: 10.1016/j.ejca.2011.03.003. Epub 2011 Mar 31.'}, {'pmid': '16083707', 'type': 'BACKGROUND', 'citation': 'Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007.'}, {'pmid': '18395079', 'type': 'BACKGROUND', 'citation': 'Pannala R, Leirness JB, Bamlet WR, Basu A, Petersen GM, Chari ST. Prevalence and clinical profile of pancreatic cancer-associated diabetes mellitus. Gastroenterology. 2008 Apr;134(4):981-7. doi: 10.1053/j.gastro.2008.01.039. Epub 2008 Jan 18.'}, {'pmid': '22960655', 'type': 'BACKGROUND', 'citation': 'Aggarwal G, Ramachandran V, Javeed N, Arumugam T, Dutta S, Klee GG, Klee EW, Smyrk TC, Bamlet W, Han JJ, Rumie Vittar NB, de Andrade M, Mukhopadhyay D, Petersen GM, Fernandez-Zapico ME, Logsdon CD, Chari ST. Adrenomedullin is up-regulated in patients with pancreatic cancer and causes insulin resistance in beta cells and mice. Gastroenterology. 2012 Dec;143(6):1510-1517.e1. doi: 10.1053/j.gastro.2012.08.044. Epub 2012 Sep 6.'}, {'pmid': '29192743', 'type': 'DERIVED', 'citation': "Antolino L, Rocca M, Todde F, Catarinozzi E, Aurello P, Bollanti L, Ramacciato G, D'Angelo F. Can pancreatic cancer be detected by adrenomedullin in patients with new-onset diabetes? The PaCANOD cohort study protocol. Tumori. 2018 Aug;104(4):312-314. doi: 10.5301/tj.5000693. Epub 2018 May 8."}]}, 'descriptionModule': {'briefSummary': 'Pancreatic Cancer is a leading cause of cancer-related death. To date, only one fifth of patients at diagnosis is presented resectable because the diagnosis is often delayed making the 5-year survival of this disease globally less than 5%. An early diagnosis in these patients is currently not possible given the economic disadvantages of a population-wide screening. New evidences identify patients with new-onset diabetes as a subgroup of patients at high risk of developing this disease (RR 5:38). In a subset of these patients a mediator secreted by the tumor, the Adrenomedullin, could be responsible for the onset of diabetes. Our goal is therefore to assess the different impact of Pancreatic Cancer depending on Adrenomedullin values in patients with newly diagnosed diabetes mellitus.', 'detailedDescription': "The study is defined as prospective observational. The research project involves the recruitment prospectively for all consecutive patients aged between 45 and 75 years receiving a new diagnosis of diabetes, according to the criteria established by the American Diabetes Association (ADA) (fasting glucose greater than or equal 126 mg / dl, or random blood glucose greater than or equal to 200 mg / dl, or glycated hemoglobin greater than or equal to 6.25%). The recruitment will take place at the Sant'Andrea Hospital. The suitability of a subject to be included in the study will be evaluated by medical history, physical examination and any further investigations carried out by a medical researcher of the team, according to the inclusion and exclusion criteria. The research team will be multidisciplinary, translational, composed of medical specialists belonging to the departments of General Surgery, Internal Medicine, Diabetology and Occupational Medicine. An informed consent will be mandatory for the recruitment in the study. At recruitment Adrenomedullin serum levels will be recorded along with every relevant clinical and laboratory data. An annual telephone follow-up will be applied and if necessary the patient will benefit of an outpatient examination. A sample size of 440 patients will achieve 80% power to detect a statistically significant difference. The 3 years clinical follow-up will allow the detection of symptoms and signs that could be related to the presence of a pancreatic mass (jaundice, pain, weight loss), further investigations will follow in such cases to confirm Pancreatic cancer diagnosis and proceed to the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients newly diagnosed of diabetes, according to the criteria established by the American Diabetes Association (ADA) (fasting glucose greater than or equal to 126 mg/dl, or random blood glucose greater than or equal to 200 mg/dl, or glycated hemoglobin greater than or equal to 6.5%)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 45 and 75 years\n* Diagnosis of diabetes mellitus made within the two years preceding the date of observation (new onset diabetes)\n* Adherence to the study documented the voluntary signing of an informed consent\n* Availability to follow a telephone follow-up\n\nExclusion Criteria:\n\n* Remote medical history (\\> 2 years) positive for diabetes mellitus\n* Previous history of malignancy\n* Pregnancy\n* Renal Failure\n* Documented diabetic microangiopathy\n* Sepsis'}, 'identificationModule': {'nctId': 'NCT02456051', 'acronym': 'PaCANOD', 'briefTitle': 'Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Role of Adrenomedullin in Early Diagnosis of Pancreatic Cancer in New Onset Diabetes Patients', 'orgStudyIdInfo': {'id': "3463_2014_D'Angelo"}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High AM', 'description': 'Newly diagnosed diabetic patients with high Adrenomedullin serum levels'}, {'label': 'Low AM', 'description': 'Newly diagnosed diabetic patients with low Adrenomedullin serum levels'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00100', 'city': 'Roma', 'country': 'Italy', 'facility': "Università Sapienza di Roma, Azienda Ospedaliera Sant'Andrea", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Laura Antolino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università Sapienza di Roma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Laura Antolino', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}