NCT04947696

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

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

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

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

June 24, 2021

Last Update Submit

June 24, 2021

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Changes in DNA-methylation patterns from the pre to postoperative setting

    Up to 30 days postoperatively

Secondary Outcomes (2)

  • Occurence of a postoperative complication

    30 days postoperatively

  • Relapse of pancreatic cancer

    2 years from time of operation

Study Arms (1)

1

Patients undergoing a Whipples procedure for pancreatic cancer

Diagnostic Test: Blood sampling

Interventions

Blood samplingDIAGNOSTIC_TEST

Blood sampling preoperatively and sequentially up to 30 days post op

1

Eligibility Criteria

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

Pancreatic cancer patients

You may qualify if:

  • Patients with pancreatic cancer scheduled for the Whipples procedure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2300, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood cells and plasma from patients undergoing a Whipples procedure

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assoc. Prof.

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 1, 2021

Study Start

July 30, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)