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

Primary Purpose

Carcinoma, Pancreatic Ductal

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
samples of blood, saliva and urine
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Pancreatic Ductal focused on measuring Antigen, CA-19-9, Salivas, body fluids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Rambam - health care campusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patients

Control

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 10, 2016
Last Updated
August 30, 2018
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02817308
Brief Title
Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas
Official Title
Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Pancreatic Ductal
Keywords
Antigen, CA-19-9, Salivas, body fluids

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
samples of blood, saliva and urine
Intervention Description
Spot samples of Blood, urine and saliva
Primary Outcome Measure Information:
Title
correlation of CA19-9 levels in urine and saliva with those in the serum
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants needed to standardize the measurements in urine and saliva according to those measured in the serum.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Offir Ben-Ishay, MD
Phone
00-972-50-2063177
Email
o_ben-ishay@Rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Offir Ben-Ishay, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam - health care campus
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Offir Ben-Ishay, MD
Phone
00-972-4-7772943
Email
o_ben-ishay@rambam.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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