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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Pancreatic Ductal

Intervention / Treatment
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* Other: samples of blood, saliva and urine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>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<br>* Spot samples of Blood, urine and saliva<br>|
| Other: Control<br>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<br>* Spot samples of Blood, urine and saliva<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of CA19-9 levels in urine and saliva with those in the serum |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antigen, CA-19-9, Salivas, body fluids