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

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ClinicalTrials.gov Identifier: NCT01675258
Recruitment Status : Unknown
Verified July 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

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.


Condition or disease Intervention/treatment
Gastric Cancer Colorectal Cancer and Pre-cancer Polyps Pancreatic Cancer Other: Salivary samples

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Salivary Analysis




Biospecimen Retention:   Samples With DNA
whole saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients identified with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer
Criteria

Inclusion Criteria:

  • Has not yet started treatment for the identified cancer

Exclusion Criteria:

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

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): NCT01675258


Locations
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Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    0097226777572    lhadas@hadassah.org.il   
Principal Investigator: Moti Moskovitz, DMD, PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Moti Moskovitz, DMD, PhD Hadassah Medical Organization
Principal Investigator: Eyal Shtayer, MD Hadassah Medical Organization
Principal Investigator: Avi Levin, MD Hadassah Medical Organization

Publications of Results:
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01675258     History of Changes
Other Study ID Numbers: LSA003-HMO-CTIL
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Polyps
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical