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

Not Applicable

• Conditions: Carcinoma, Pancreatic Ductal
• Interventions: Other: samples of blood, saliva and urine

• Registration Number: NCT02817308
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-06-26
• Study First Posted: 2016-06-29
• Study Start: 2016-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-08-31
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	samples of blood, saliva and urine	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
Control	samples of blood, saliva and urine	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

Primary Outcome Measures

Name	Time	Method
correlation of CA19-9 levels in urine and saliva with those in the serum	1 year

Secondary Outcome Measures

Name	Time	Method
Number of participants needed to standardize the measurements in urine and saliva according to those measured in the serum.	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.

Trial Locations

Locations (1)

Rambam - health care campus; 🇮🇱 Haifa, Israel