OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol

August 4, 2014 updated by: Eventus Diagnostics Ltd

OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol

The OctavaColon tests are qualitative plasma tests that are indicated to people above 18 years of age suspected with colon abnormality. The blood tests will provide additional information to the doctor in the course of colon cancer diagnosis for both normal population and high risk population

Study Overview

Status

Unknown

Conditions

Detailed Description

The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -

  1. Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.
  2. Highly sensitive (OctavaSilver) - provides additional information to doctors during evaluation of high risk population.

The study will be considered successful it can achieve at least one of the following sets of performances -

  1. For the OctavaGold - 95% specificity with at least 50% sensitivity.
  2. For the OctavaSilver - 95% sensitivity with at least 50% specificity. The biological objective of this study is to find the best set of antigens, that when combined with the appropriate algorithm will support each of the above clinical objectives

Study Type

Observational

Enrollment (Anticipated)

1080

Contacts and Locations

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

Study Contact

Study Locations

  • Israel
      • Beer Sheva, Israel, 85025
        • Not yet recruiting
        • Soroka Medical Center
        • Contact:
        • Principal Investigator:
          • Gilbert Sabag, MD
      • Haifa, Israel, 34362
        • Not yet recruiting
        • "Carmel" Medical Center
        • Contact:
        • Principal Investigator:
          • Arie Bitterman, MD
        • Sub-Investigator:
          • Lilly Merdler, MD
        • Sub-Investigator:
          • Dabbah Kamal, MD
      • Ramat gan, Israel, 52621

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

There are 3 different populations that will participate in the study-

  1. Any person with suspected colon abnormality, that will be classified after colonoscopy/surgery as "colon cancer patient" will be a part of group1 - "Patient".
  2. Any person with suspected colon abnormality, that will be classified after colonoscopy as "benign polyp" will be a part of group2 - "benign".
  3. Any person with suspected colon abnormality, that will be classified after colonoscopy as "normal/healthy" will be a part of group0 - "healthy".

Description

Inclusion Criteria:

Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery

Exclusion Criteria:

  • Subjects less than 18 years of age
  • Previous or concurrent synchronous cancers other than previous malignancies of the colon and recovered melanoma
  • Autoimmune disorders diagnosed subjects
  • Hematological malignancies
  • Subjects under active chemotherapy treatment or chemotherapy in the past 6 months
  • Steroid treatment in the past 3 months
  • Subject undergoing immunosuppressive treatments
  • Subject with verified melanoma colon cancer
  • Subject with verified sarcoma colon cancer

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
healthy_0
healthy, people with normal (negative) colonoscopy results.
patient_1
people with biopsy/surgery verified carcinoma of the colon, either an Adenocarcinoma, or carcinoma in situ
benign_2
people with biopsy verified benign polyps of the colon one of the following - Villus adenoma, Tubular adenoma, Low grade dysplasia, Intermediate grade dysplasia, High grade dysplasia, Severe dysplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants in each of the clinicaly defined groups (0,1 and 2).
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Eventus Diagnostics Ltd

Investigators

  • Study Director: Galit Yahalom, Ph.D., Eventus Dx

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

August 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

February 9, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OctavaColon_001

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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