Pancreatic Cancer Initial Detection Via Liquid Biopsy (PANCAID)

April 23, 2024 updated by: Matthias Löhr, Karolinska University Hospital
The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas [N0M0]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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

  • Sweden
      • Stockholm, Sweden, 14186
        • Gastrocentrum, KarolinskaUniversity Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults capable of giving informed consent to give blood for liquid biopsy coming to the University Hospitals of Stockhol (Karolinska) and Umeå

Description

Inclusion Criteria:

  • Suspicion of or elevated risk for pancreatic ductal adenocarcinoma (PDAC); intraductal papillary mucinous neoplasias (IPMN); individuals at risk (IAR) for pancreatic cancer

Exclusion Criteria:

  • other malignant condition

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
Healthy controls
Diagnostic test: Liquid biopsy
Blood will be drawn upon clinical diagnosis / prior to biopsy/surgical resection for "ground truth"
Pancreatic cancer, early
Early pancreatic cancer, T1/T2 NoM0
Diagnostic test: Liquid biopsy
Blood will be drawn upon clinical diagnosis / prior to biopsy/surgical resection for "ground truth"
IPMN
Diagnostic test: Liquid biopsy
Blood will be drawn upon clinical diagnosis / prior to biopsy/surgical resection for "ground truth"
Pancreatic cancer, advanced
Advance pancreatic cancer T1-4, Nx, Mx
Diagnostic test: Liquid biopsy
Blood will be drawn upon clinical diagnosis / prior to biopsy/surgical resection for "ground truth"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer detection
Time Frame: Up to 4 weeks after surgery
Liquid biopsy test(s) detecting pancreatic cancer on biobanked, archival samples of patients with histologically confirmed pancreatic lesions (PDAC, IPMN, pancreatitis).
Up to 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 month - 24 months after surgical resection of the tumor
Overall survival
1 month - 24 months after surgical resection of the tumor

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Collaborators

Umeå University

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANCAID-00-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request to the PANCAID consortium

IPD Sharing Time Frame

after completion of the study

IPD Sharing Access Criteria

Clearance from Scientifc and Ethical Advisory Board of PANCAID (see www.pancaid-project.eu/)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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