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

Rambam Health Care Campus

Status: Unknown

Conditions: Carcinoma, Pancreatic Ductal

Treatments: Other: samples of blood, saliva and urine

Study type: Interventional

Funder types: Other

Identifiers

NCT02817308

CA19-90415-15-RMBCTIL

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Patients

Experimental group

Description:

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

Treatment:

Other: samples of blood, saliva and urine

Control

Other group

Description:

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

Treatment:

Other: samples of blood, saliva and urine