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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02066259
• Other study ID #: OctavaColon_001
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2014
• Last updated: August 4, 2014
• Start date: August 2014
• Est. completion date: March 2018

Study information

• Verified date: August 2014
• Source: Eventus Diagnostics Ltd
• Contact: Galit Yahalom, Ph.D
• Phone: +972546922422
• Email: galit[@]eventusdx.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1080
• Est. completion date: March 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer Sheva
Israel	"Carmel" Medical Center	Haifa
Israel	Sheba Tel hashomer	Ramat gan

Sponsors (1)

Lead Sponsor	Collaborator
Eventus Diagnostics Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in each of the clinicaly defined groups (0,1 and 2).		3 years	No