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

NCT02817308 | Unknown

• 1 other identifier: CA19-90415-15-RMBCTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Pancreatic Ductal

Keywords

Antigen, CA-19-9; Salivas; body fluids

Outcome Measures

Primary Outcomes (1)

• correlation of CA19-9 levels in urine and saliva with those in the serum

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (2)

Patients

EXPERIMENTAL

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: samples of blood, saliva and urine

Control

OTHER

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

Other: samples of blood, saliva and urine

Interventions

samples of blood, saliva and urine OTHER

Spot samples of Blood, urine and saliva

Control; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Controls:
• Previous diagnosis of malignancy

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam - health care campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Interventions

Urination

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Offir Ben-Ishay, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Offir Ben-Ishay, MD

CONTACT

00-972-50-2063177; o_ben-ishay@Rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: June 29, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)