Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas

Overview

Ductal adenocarcinoma of the pancreas is the fifth leading cause of cancer related deaths in the European Union. Tumor markers CA19-9 and carcinoembryonic antigen are important components in decision making and follow-up of patients diagnosed with this disease. These tumor markers were found to be elevated not only in the serum but also in other body fluids in patients with malignant lesions of the parotid gland and the urinary tract. The authors have described in a previews small preliminary study a positive and a strong linear correlation between the levels of CA19-9 in urine and saliva with those presented in the serum of patients with ductal adenocarcinoma of the pancreas. The current study seeks to enlarge the study population to confirm the previous results and standardize the measured levels of CA19-9 in these body fluids.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2020

Interventions

  • Other: samples of blood, saliva and urine
    • Spot samples of Blood, urine and saliva

Arms, Groups and Cohorts

  • Experimental: Patients
    • Patients with a proven diagnosis of ductal adenocarcinoma of the pancreas with elevated levels of CA19-9 and possibly elevated CEA levels. intervention: samples of blood, saliva and urine
  • Other: Control
    • Patients or healthy volunteers with out a known evidence of malignancy with presumably normal levels of CA19-9 and CEA. intervention: samples of blood, saliva and urine

Clinical Trial Outcome Measures

Primary Measures

  • correlation of CA19-9 levels in urine and saliva with those in the serum
    • Time Frame: 1 year

Secondary Measures

  • Number of participants needed to standardize the measurements in urine and saliva according to those measured in the serum.
    • Time Frame: 1 year
    • upper and lower levels of CA19-9 measured in urine and saliva are not yet standardized. and repeated measurements in these body fluids compared to the ones in serum of healthy subjects are needed for such standardization.

Participating in This Clinical Trial

Inclusion Criteria

Patients:

  • Proven diagnosis of ductal adenocarcinoma of the pancreas – elevated levels of CA19-9 – possible elevated levels of CEA Exclusion Criteria:

Controls:

  • Previous diagnosis of malignancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Offir Ben-Ishay, MD, Principal Investigator, Rambam Health Care Campus
  • Overall Contact(s)
    • Offir Ben-Ishay, MD, 00-972-50-2063177, o_ben-ishay@Rambam.health.gov.il

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