Circulating Epigenetics in Pancreatic Surgery

June 24, 2021 updated by: Martin Sillesen, Rigshospitalet, Denmark

Towards Precision Medicine in Pancreatic Surgery - an Integrative Approach Combining Deep Learning, Genetics and Epigenetics

The overall objective of the study is to assess DNA-methylation changes in circulating blood cells and cell free DNA in plasma from patients undergoing the Whipples procedure for pancreatic caner

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2300
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Martin Sillesen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pancreatic cancer patients

Description

Inclusion Criteria:

  • Patients with pancreatic cancer scheduled for the Whipples procedure

Exclusion Criteria:

  • Under 18 years of age
  • Pregnancy
  • Unable to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients undergoing a Whipples procedure for pancreatic cancer
Diagnostic test: Blood sampling
Blood sampling preoperatively and sequentially up to 30 days post op

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in DNA-methylation patterns from the pre to postoperative setting
Time Frame: Up to 30 days postoperatively
Up to 30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurence of a postoperative complication
Time Frame: 30 days postoperatively
30 days postoperatively
Relapse of pancreatic cancer
Time Frame: 2 years from time of operation
2 years from time of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 30, 2021

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (ACTUAL)

July 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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