Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
Study NCT ID:
NCT02066259
Status:
UNKNOWN
Last Update Posted:
2014-08-05
First Post:
2014-02-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
Sponsor:
Eventus Diagnostics Ltd
Organization:
Study Overview
Official Title:
OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: