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
1 other identifier
observational
1,080
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedAugust 5, 2014
August 1, 2014
1.6 years
February 9, 2014
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants in each of the clinicaly defined groups (0,1 and 2).
3 years
Study Arms (3)
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
Eligibility Criteria
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".
You may qualify if:
- Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Soroka Medical Center
Beersheba, 85025, Israel
"Carmel" Medical Center
Haifa, 34362, Israel
Sheba Tel hashomer
Ramat Gan, 52621, Israel
Related 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.
PMID: 24324350BACKGROUND
Biospecimen
Human plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Galit Yahalom, Ph.D.
Eventus Dx
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2014
First Posted
February 19, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2018
Last Updated
August 5, 2014
Record last verified: 2014-08