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Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients

NCT ID: NCT02456051

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Neoplasm Diabetes Mellitus, Adult-Onset Diabetes Complications Carcinoma, Pancreatic Ductal

Keywords

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Pancreatic Carcinoma New-Onset Diabetes Adrenomedullin Early Diagnosis Biological Markers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High AM

Newly diagnosed diabetic patients with high Adrenomedullin serum levels

No interventions assigned to this group

Low AM

Newly diagnosed diabetic patients with low Adrenomedullin serum levels

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age between 45 and 75 years
* Diagnosis of diabetes mellitus made within the two years preceding the date of observation (new onset diabetes)
* Adherence to the study documented the voluntary signing of an informed consent
* Availability to follow a telephone follow-up

Exclusion Criteria

* Remote medical history (\> 2 years) positive for diabetes mellitus
* Previous history of malignancy
* Pregnancy
* Renal Failure
* Documented diabetic microangiopathy
* Sepsis
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Laura Antolino

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Antolino, MD

Role: PRINCIPAL_INVESTIGATOR

Università Sapienza di Roma

Locations

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Università Sapienza di Roma, Azienda Ospedaliera Sant'Andrea

Roma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 22895395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18061176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20981102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15886696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21458985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16083707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18395079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22960655 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29192743 (View on PubMed)

Other Identifiers

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3463_2014_D'Angelo

Identifier Type: -

Identifier Source: org_study_id