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

NCT ID: NCT02817308

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-01-31

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.

Detailed Description

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Conditions

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Carcinoma, Pancreatic Ductal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

samples of blood, saliva and urine

Intervention Type OTHER

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

Group Type OTHER

samples of blood, saliva and urine

Intervention Type OTHER

Spot samples of Blood, urine and saliva

Interventions

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samples of blood, saliva and urine

Spot samples of Blood, urine and saliva

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Offir Ben-Ishay, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam - health care campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Offir Ben-Ishay, MD

Role: CONTACT

00-972-50-2063177

Facility Contacts

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Offir Ben-Ishay, MD

Role: primary

00-972-4-7772943

Other Identifiers

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CA19-90415-15-RMBCTIL

Identifier Type: -

Identifier Source: org_study_id

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