NovellusDx Cancer Early Detection Blood Test- Clinical Trial

March 27, 2018 updated by: Fore Biotherapeutics

Assessing the Ability of An Innovative Screening Method To Identify Proteomic Changes In Cancer Patients- Protocol

NovellusDx early detection test is a simple to perform blood test, which identifies the deregulated signaling pathways within the patient tumor based on protein secretion to the blood, thus enabling early stage disease signature detection. The investigators' current clinical trial is focused on proving the main feature of NovellusDx's Early Detection Test- discriminating between cancer patients and healthy subjects.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy subjects and subjects with primary / relapsed lung cancer

Description

Inclusion Criteria:

  • subjects ages 18 and above ICF obtain

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a significant cancer fingerprint as measured by NovellusDX Cancer Early Detection test
Time Frame: 3.5 years
NovellusDX Cancer Early Detection test will identify participants with significant cancer fingerprint based on tumor protein secretion to the blood circulation in sick subjects.
3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fore Biotherapeutics

Investigators

  • Principal Investigator: Yishai Ofran, MD, Rambam MC. Haematology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAM-NOVEL-211-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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