NCT01675258

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

August 29, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

August 27, 2012

Last Update Submit

August 27, 2012

Conditions

Study Arms (2)

Control

Healthy adults above the age of 18 years

Other: Salivary samples

Study

Adult patients above the age of 18 years with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer

Other: Salivary samples

Interventions

Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.

Also known as: Salivary Analysis
ControlStudy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Has not yet started treatment for the identified cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (1)

  • Zhang L, Farrell JJ, Zhou H, Elashoff D, Akin D, Park NH, Chia D, Wong DT. Salivary transcriptomic biomarkers for detection of resectable pancreatic cancer. Gastroenterology. 2010 Mar;138(3):949-57.e1-7. doi: 10.1053/j.gastro.2009.11.010. Epub 2009 Nov 18.

Biospecimen

Retention: SAMPLES WITH DNA

whole saliva

MeSH Terms

Conditions

Stomach NeoplasmsColorectal NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Moti Moskovitz, DMD, PhD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
  • Eyal Shtayer, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
  • Avi Levin, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2012

First Posted

August 29, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Last Updated

August 29, 2012

Record last verified: 2012-07

Locations