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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02817308
Enrollment
100
Registered
2016-06-29
Start date
2016-07-31
Completion date
2020-01-31
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Pancreatic Ductal

Keywords

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

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.

Interventions

OTHERsamples of blood, saliva and urine

Spot samples of Blood, urine and saliva

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
correlation of CA19-9 levels in urine and saliva with those in the serum1 year

Secondary

MeasureTime frameDescription
Number of participants needed to standardize the measurements in urine and saliva according to those measured in the serum.1 yearupper 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.

Countries

Israel

Contacts

Primary ContactOffir Ben-Ishay, MD
o_ben-ishay@Rambam.health.gov.il00-972-50-2063177

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026