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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01675258
Other study ID # LSA003-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 27, 2012
Last updated August 27, 2012
Start date September 2012

Study information

Verified date July 2012
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Intervention

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

Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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 — View Citation

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