Pancreatic Cancer Initial Detection Via Liquid Biopsy

NCT06283576 | Enrolling By Invitation DMC

• 1 other identifier: PANCAID-00-08
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pancreatic Cancer; IPMN, Pancreatic; Individuals at Risk; Chronic Pancreatitis

Keywords

diabetes mellitus; smoking

Outcome Measures

Primary Outcomes (1)

• Cancer detection

  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 Outcomes (1)

• Overall survival

  1 month - 24 months after surgical resection of the tumor

Study Arms (4)

Pancreatic cancer, early

Early pancreatic cancer, T1/T2 NoM0

Diagnostic Test: Liquid biopsy

IPMN

Diagnostic Test: Liquid biopsy

Pancreatic cancer, advanced

Advance pancreatic cancer T1-4, Nx, Mx

Diagnostic Test: Liquid biopsy

Healthy controls

Diagnostic Test: Liquid biopsy

Interventions

Liquid biopsy DIAGNOSTIC_TEST

Blood will be drawn upon clinical diagnosis / prior to biopsy/surgical resection for "ground truth"

Healthy controls; IPMN; Pancreatic cancer, advanced; Pancreatic cancer, early

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• other malignant condition

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Umeå University: collaborator

Study Sites (1)

Gastrocentrum, KarolinskaUniversity Hospital

Stockholm, 14186, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liquid biopsy: ct-DNA, extracellular vesicles, proeomics, metabolomics, CTC

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Intraductal Neoplasms; Pancreatitis, Chronic; Diabetes Mellitus; Smoking

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology & Hepatology

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completion of the study
• Access Criteria: Clearance from Scientifc and Ethical Advisory Board of PANCAID (see www.pancaid-project.eu/)

Locations

SE (1)