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Trial Title: Pancreatic Cancer Initial Detection Via Liquid Biopsy

NCT ID: NCT06283576

Condition: Pancreatic Cancer
IPMN, Pancreatic
Individuals at Risk
Chronic Pancreatitis

Conditions: Official terms:
Pancreatic Neoplasms
Pancreatic Intraductal Neoplasms
Pancreatitis
Pancreatitis, Chronic

Conditions: Keywords:
diabetes mellitus
smoking

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Liquid biopsy
Description: Blood will be drawn upon clinical diagnosis / prior to biopsy/surgical resection for "ground truth"
Arm group label: Healthy controls
Arm group label: IPMN
Arm group label: Pancreatic cancer, advanced
Arm group label: Pancreatic cancer, early

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).

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Gastrocentrum, KarolinskaUniversity Hospital

Address:
City: Stockholm
Zip: 14186
Country: Sweden

Start date: May 1, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Karolinska University Hospital
Agency class: Other

Collaborator:
Agency: Umeå University
Agency class: Other

Source: Karolinska University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06283576

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