NCT02079363

Brief Summary

The objectives of this project are to test whether alteration in DNA hypermethylation in plasma is:

  • a diagnostic marker for pancreatic cancer
  • a prognostic marker for pancreatic cancer
  • a marker for recurrence of pancreatic cancer
  • changing during the course of chronic pancreatitis, with the purpose of finding patients with high risk of developing pancreatic cancer

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

4 years

First QC Date

March 4, 2014

Last Update Submit

July 29, 2014

Conditions

Pancreatic DiseasesPancreatic NeoplasmsPancreatitis

Keywords

Pancreatic DiseasesPancreatic NeoplasmsPancreatitisDNA promoter hypermethylationDNA methylationCell-free DNAPlasma

Outcome Measures

Primary Outcomes (1)

  • Number of methylated genes for each participant.

    We investigate the methylation status a of panel of 20 different genes in cell-free DNA in plasma. Plasma from patients with c. pancreas will be compared to plasma from patients in the control groups to se if DNA promoter hypermethylation can be used as a diagnostic marker for pancreas cancer.

    Time of diagnosis

Secondary Outcomes (1)

  • Number of methylated genes for each participant related to prognosis

    2 years follow up

Other Outcomes (2)

  • Number of methylated genes in patients who are undergoing curative surgery.

    2 years follow up

  • Number of methylated genes in patients with chronic pancreatitis.

    2 years follow up

Study Arms (4)

Patients with pancreatic adenocarcinoma

Exclusion criteria: No prior cancer. No anticoagulant treatment.

Other: No interventions, this is an observational study

Patients with chronic pancreatitis

Exclusion criteria: No prior cancer. No anticoagulant treatment.

Other: No interventions, this is an observational study

Patients with acute pancreatitis

Exclusion criteria: No prior cancer.

Other: No interventions, this is an observational study

Patients screened for but not having upper GI cancer

Exclusion criteria: No prior cancer.

Other: No interventions, this is an observational study

Interventions

No interventions, this is an observational studyOTHER
Patients screened for but not having upper GI cancerPatients with acute pancreatitisPatients with chronic pancreatitisPatients with pancreatic adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pancreatic adenocarcinoma, who were referred to Aalborg University Hospital between 2008 and 2012. Blodsamples are stored in a biobank. Patients with chronic pancreatitis, who are hospitalized or have an outpatient visit at Aalborg University Hospital. Patients with acute pancreatitis, who are hospitalized at Aalborg University Hospital. Patients who are referred to Aalborg University Hospital for suspected upper GI cancer. Subsequent examinations invalidate the cancer diagnosis.

You may qualify if:

  • Patients with chronic pancreatitis who are hospitalized or have an outpatient visit at Aalborg University Hospital Or
  • Patients hospitalized at Aalborg University Hospital, with acute pancreatitis verified by UL, CT or MR-scan and/or increased s-amylase

You may not qualify if:

  • Prior cancer history.
  • Anticoagulant therapy.
  • Immunological tissue disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research unit, Surgical Department of Gastroenterology, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (7)

  • Park JW, Baek IH, Kim YT. Preliminary study analyzing the methylated genes in the plasma of patients with pancreatic cancer. Scand J Surg. 2012;101(1):38-44. doi: 10.1177/145749691210100108.

    PMID: 22414467BACKGROUND

  • Melson J, Li Y, Cassinotti E, Melnikov A, Boni L, Ai J, Greenspan M, Mobarhan S, Levenson V, Deng Y. Commonality and differences of methylation signatures in the plasma of patients with pancreatic cancer and colorectal cancer. Int J Cancer. 2014 Jun 1;134(11):2656-62. doi: 10.1002/ijc.28593. Epub 2013 Nov 29.

    PMID: 24288256BACKGROUND

  • Park JK, Ryu JK, Yoon WJ, Lee SH, Lee GY, Jeong KS, Kim YT, Yoon YB. The role of quantitative NPTX2 hypermethylation as a novel serum diagnostic marker in pancreatic cancer. Pancreas. 2012 Jan;41(1):95-101. doi: 10.1097/MPA.0b013e318221c903.

    PMID: 21778928BACKGROUND

  • Liggett T, Melnikov A, Yi QL, Replogle C, Brand R, Kaul K, Talamonti M, Abrams RA, Levenson V. Differential methylation of cell-free circulating DNA among patients with pancreatic cancer versus chronic pancreatitis. Cancer. 2010 Apr 1;116(7):1674-80. doi: 10.1002/cncr.24893.

    PMID: 20143430BACKGROUND

  • Jiao L, Zhu J, Hassan MM, Evans DB, Abbruzzese JL, Li D. K-ras mutation and p16 and preproenkephalin promoter hypermethylation in plasma DNA of pancreatic cancer patients: in relation to cigarette smoking. Pancreas. 2007 Jan;34(1):55-62. doi: 10.1097/01.mpa.0000246665.68869.d4.

    PMID: 17198183BACKGROUND

  • Yi JM, Guzzetta AA, Bailey VJ, Downing SR, Van Neste L, Chiappinelli KB, Keeley BP, Stark A, Herrera A, Wolfgang C, Pappou EP, Iacobuzio-Donahue CA, Goggins MG, Herman JG, Wang TH, Baylin SB, Ahuja N. Novel methylation biomarker panel for the early detection of pancreatic cancer. Clin Cancer Res. 2013 Dec 1;19(23):6544-6555. doi: 10.1158/1078-0432.CCR-12-3224. Epub 2013 Oct 2.

    PMID: 24088737BACKGROUND

  • Henriksen SD, Madsen PH, Larsen AC, Johansen MB, Drewes AM, Pedersen IS, Krarup H, Thorlacius-Ussing O. Cell-free DNA promoter hypermethylation in plasma as a diagnostic marker for pancreatic adenocarcinoma. Clin Epigenetics. 2016 Nov 16;8:117. doi: 10.1186/s13148-016-0286-2. eCollection 2016.

    PMID: 27891190DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Cell free methylated DNA in EDTA plasma

MeSH Terms

Conditions

Pancreatic DiseasesPancreatic NeoplasmsPancreatitis

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System Diseases

Study Officials

  • Stine Dam Henriksen, MD

    Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Ole Thorlacius-Ussing, MD,DMSc,Prof

    Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark

    STUDY CHAIR

Central Study Contacts

Stine Dam Henriksen, MD

CONTACT

+45 97661210stdh@rn.dk

June Lundtoft

CONTACT

+45 97661131

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc, Consultant surgeant, Professor of Surgery

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 5, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2017

Study Completion

January 1, 2018

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

DK(1)