Circulating Epigenetics in Pancreatic Surgery
Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04947696
Collaborator
(none)
200
1
23
8.7
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Towards Precision Medicine in Pancreatic Surgery - an Integrative Approach Combining Deep Learning, Genetics and Epigenetics
Anticipated Study Start Date
:
Jul 30, 2021
Anticipated Primary Completion Date
:
Jul 1, 2022
Anticipated Study Completion Date
:
Jul 1, 2023
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Changes in DNA-methylation patterns from the pre to postoperative setting [Up to 30 days postoperatively]
Secondary Outcome Measures
- Occurence of a postoperative complication [30 days postoperatively]
- Relapse of pancreatic cancer [2 years from time of operation]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with pancreatic cancer scheduled for the Whipples procedure
Exclusion Criteria:
-
Under 18 years of age
-
Pregnancy
-
Unable to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet | Copenhagen | Denmark | 2300 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Martin Sillesen,
MD, PhD, Assoc. Prof.,
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT04947696
Other Study ID Numbers:
- 70711
First Posted:
Jul 1, 2021
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: