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
-
-
-
Copenhagen, Denmark, 2300
- Recruiting
- Rigshospitalet
-
Contact:
- Martin Sillesen, MD, PhD
- Phone Number: 35452122
- Email: martin.sillesen@regionh.dk
-
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
|
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
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.