Pancreatic Cancer Initial Detection Via Liquid Biopsy

NCT ID: NCT06283576

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pancreatic cancer, early

Early pancreatic cancer, T1/T2 NoM0

Liquid biopsy

Intervention Type: DIAGNOSTIC_TEST

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

IPMN

Liquid biopsy

Intervention Type: DIAGNOSTIC_TEST

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

Liquid biopsy

Intervention Type: DIAGNOSTIC_TEST

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

Healthy controls

Liquid biopsy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Liquid biopsy

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umeå University

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Matthias Löhr

Professor of Gastroenterology & Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gastrocentrum, KarolinskaUniversity Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

PANCAID-00-08

Identifier Type: -

Identifier Source: org_study_id