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

Carcinoma, Pancreatic Ductal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817308
• Other study ID #: CA19-90415-15-RMBCTIL
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 2020

Study information

• Verified date: August 2018
• Source: Rambam Health Care Campus
• Contact: Offir Ben-Ishay, MD
• Phone: 00-972-50-2063177
• Email: o_ben-ishay[@]Rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Pancreatic Ductal

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam - health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of CA19-9 levels in urine and saliva with those in the serum		1 year
Secondary	Number of participants needed to standardize the measurements in urine and saliva according to those measured in the serum.	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.	1 year