Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers

August 27, 2012 updated by: Hadassah Medical Organization

Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.

Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.

The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients identified with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer

Description

Inclusion Criteria:

  • Has not yet started treatment for the identified cancer

Exclusion Criteria:

  • medically compromised patients
  • congenital syndromes
  • being treated with radiotherapy or chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Healthy adults above the age of 18 years
Other: Salivary samples
Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.
Other Names:
  • Salivary Analysis
Study
Adult patients above the age of 18 years with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer
Other: Salivary samples
Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.
Other Names:
  • Salivary Analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Eyal Shtayer, MD, Hadassah Medical Organization
  • Principal Investigator: Avi Levin, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSA003-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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