Pancreatic Cancer Initial Detection Via Liquid Biopsy

• Conditions: IPMN, Pancreatic; Individuals at Risk; Chronic Pancreatitis; Pancreatic Cancer
• Interventions: Diagnostic Test: Liquid biopsy

• Registration Number: NCT06283576
• Lead Sponsor: Karolinska University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Study Start: 2024-05-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatic cancer, early	Liquid biopsy	Early pancreatic cancer, T1/T2 NoM0
Healthy controls	Liquid biopsy	-
IPMN	Liquid biopsy	-
Pancreatic cancer, advanced	Liquid biopsy	Advance pancreatic cancer T1-4, Nx, Mx

Primary Outcome Measures

Name	Time	Method
Cancer detection	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).

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 month - 24 months after surgical resection of the tumor	Overall survival

Trial Locations

Locations (1)

Gastrocentrum, KarolinskaUniversity Hospital; 🇸🇪 Stockholm, Sweden