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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02066259
Other study ID # OctavaColon_001
Secondary ID
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


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
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