NCT02456051

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

2.6 years

First QC Date

May 25, 2015

Last Update Submit

November 17, 2017

Conditions

Diabetes Mellitus, Adult-OnsetDiabetes ComplicationsCarcinoma, Pancreatic DuctalPancreatic Neoplasm

Keywords

Pancreatic CarcinomaNew-Onset DiabetesAdrenomedullinEarly DiagnosisBiological Markers

Outcome Measures

Primary Outcomes (1)

  • Pancreatic cancer diagnosis

    3 years

Secondary Outcomes (1)

  • Mortality

    3 years

Study Arms (2)

High AM

Newly diagnosed diabetic patients with high Adrenomedullin serum levels

Low AM

Newly diagnosed diabetic patients with low Adrenomedullin serum levels

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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%)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Sapienza di Roma, Azienda Ospedaliera Sant'Andrea

Roma, 00100, Italy

Location

Related Publications (9)

  • 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: 22895395BACKGROUND

  • 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: 18061176BACKGROUND

  • 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: 20981102BACKGROUND

  • 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: 15886696BACKGROUND

  • 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: 21458985BACKGROUND

  • 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: 16083707BACKGROUND

  • 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: 18395079BACKGROUND

  • 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: 22960655BACKGROUND

  • 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.

    PMID: 29192743DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes ComplicationsCarcinoma, Pancreatic DuctalPancreatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Antolino, MD

    Università Sapienza di Roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 25, 2015

First Posted

May 28, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

IT(1)