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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02066259

Enrollment

1080

Registered

2014-02-19

Start date

2014-08-31

Completion date

2018-03-31

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

colon cancer, cancer associated auto antibodies, colon cancer blood test

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

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Israel

Contacts

Primary ContactGalit Yahalom, Ph.D

galit@eventusdx.com+972546922422

Outcome results