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NCT06283576 Clinical Trial

Pancreatic Cancer Initial Detection Via Liquid Biopsy

Pancreatic Cancer Clinical Trial

— PANCAID  

Official title:
Pancreatic Cancer Initial Detection Via Liquid Biopsy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06283576
Other study ID # PANCAID-00-08
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date December 31, 2027

Study information
Verified date April 2024
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Liquid biopsy
Blood will be drawn upon clinical diagnosis / prior to biopsy/surgical resection for "ground truth"

Locations
Country Name City State
Sweden Gastrocentrum, KarolinskaUniversity Hospital Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska University Hospital Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Overall survival Overall survival 1 month - 24 months after surgical resection of the tumor
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