Colon CancerNCT02066259
OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
An observational study of Colon Cancer, run by Eventus Diagnostics Ltd at 3 sites in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- How many people
- 1,080 participants
- Where
- 3 sitesIsrael
- Study dates
- Aug 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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".
Who may be able to join
- Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery
Who cannot join
- 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
Show all 9Show fewer
- Subject undergoing immunosuppressive treatments
- Subject with verified melanoma colon cancer
- Subject with verified sarcoma colon cancer
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Not yet recruiting
Soroka Medical Center
Beersheba, 85025
Gilbert Sabag, MD, GilbertS@clalit.org.il
Gilbert Sabag, MD
- Not yet recruiting
"Carmel" Medical Center
Haifa, 34362
Arie Bitterman, MD, bitterman@clalit.org.il
Arie Bitterman, MD
- Recruiting
Sheba Tel hashomer
Ramat Gan, 52621
Adi Lahat, MD, Adi.Lahat@sheba.health.gov.il
Adi Lahat, MD
About this study
Official title: OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
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
Read the detailed description
The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -
- Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.
- 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 -
- For the OctavaGold - 95% specificity with at least 50% sensitivity.
- 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
- Conditions
- Colon Cancer
- Keywords
- colon cancer, cancer associated auto antibodies, colon cancer blood test
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each of the clinicaly defined groups (0,1 and 2).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eventus Diagnostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galit Yahalom, Ph.D., Study director, Eventus Dx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066259
- Sponsor's protocol ID
- OctavaColon_001
- Status last verified
- Aug 2014
- First submitted
- 9 Feb 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24324350
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT02066259
- Acronym / sponsor ID
- OctavaColon_001
- Conditions
- Colon Cancer
- Keywords
- colon cancer, cancer associated auto antibodies, colon cancer blood test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Eventus Diagnostics LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 -
- Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.
- 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 -
- For the OctavaGold - 95% specificity with at least 50% sensitivity.
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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".
Key inclusion criteria (1 listed)
- Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants in each of the clinicaly defined groups (0,1 and 2).
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Background: PubMed 24324350Yahalom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galit Yahalom, Ph.D. study director
Eventus Dx
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Eventus Diagnostics Ltd at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galit Yahalom, Ph.D (+972546922422, galit@eventusdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in each of the clinicaly defined groups (0,1 and 2). (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.