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

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ClinicalTrials.gov Identifier: NCT02066259
Recruitment Status : Unknown
Verified August 2014 by Eventus Diagnostics Ltd.
Recruitment status was:  Recruiting
First Posted : February 19, 2014
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Eventus Diagnostics Ltd

Brief Summary:
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

Condition or disease
Colon Cancer

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

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Study Type : Observational
Estimated Enrollment : 1080 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
Study Start Date : August 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2018

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



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

Biospecimen Retention:   Samples With DNA
Human plasma samples


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:   Yes
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".
Criteria

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

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): NCT02066259


Contacts
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Contact: Galit Yahalom, Ph.D +972546922422 galit@eventusdx.com

Locations
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Israel
Soroka Medical Center Not yet recruiting
Beer Sheva, Israel, 85025
Contact: Gilbert Sabag, MD       GilbertS@clalit.org.il   
Principal Investigator: Gilbert Sabag, MD         
"Carmel" Medical Center Not yet recruiting
Haifa, Israel, 34362
Contact: Arie Bitterman, MD       bitterman@clalit.org.il   
Principal Investigator: Arie Bitterman, MD         
Sub-Investigator: Lilly Merdler, MD         
Sub-Investigator: Dabbah Kamal, MD         
Sheba Tel hashomer Recruiting
Ramat gan, Israel, 52621
Contact: Adi Lahat, MD       Adi.Lahat@sheba.health.gov.il   
Principal Investigator: Adi Lahat, MD         
Sponsors and Collaborators
Eventus Diagnostics Ltd
Investigators
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Study Director: Galit Yahalom, Ph.D. Eventus Dx

Publications:
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Responsible Party: Eventus Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT02066259     History of Changes
Other Study ID Numbers: OctavaColon_001
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014
Keywords provided by Eventus Diagnostics Ltd:
colon cancer
cancer associated auto antibodies
colon cancer blood test
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases