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NCT04947696 Clinical Trial

Circulating Epigenetics in Pancreatic Surgery

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04947696
Other study ID # 70711
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 30, 2021
Est. completion date July 1, 2023

Study information
Verified date June 2021
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 1, 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sampling
Blood sampling preoperatively and sequentially up to 30 days post op

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in DNA-methylation patterns from the pre to postoperative setting Up to 30 days postoperatively
Secondary Occurence of a postoperative complication 30 days postoperatively
Secondary Relapse of pancreatic cancer 2 years from time of operation
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