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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817308
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Other: samples of blood, saliva and urine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas
Study Start Date : July 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients

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
Spot samples of Blood, urine and saliva

Control

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
Spot samples of Blood, urine and saliva




Primary Outcome Measures :
  1. correlation of CA19-9 levels in urine and saliva with those in the serum [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of participants needed to standardize the measurements in urine and saliva according to those measured in the serum. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817308


Contacts
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Contact: Offir Ben-Ishay, MD 00-972-50-2063177 o_ben-ishay@Rambam.health.gov.il

Locations
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Israel
Rambam - health care campus Recruiting
Haifa, Israel
Contact: Offir Ben-Ishay, MD    00-972-4-7772943    o_ben-ishay@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Offir Ben-Ishay, MD Rambam Health Care Campus

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02817308    
Other Study ID Numbers: CA19-90415-15-RMBCTIL
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rambam Health Care Campus:
Antigen, CA-19-9
Salivas
body fluids
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Pancreatic Ductal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents