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NovellusDx Cancer Early Detection Blood Test- Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883388
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
NovellusDx

Brief Summary:
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.

Condition or disease
Lung Cancer

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Ability of An Innovative Screening Method To Identify Proteomic Changes In Cancer Patients- Protocol
Study Start Date : June 2013
Actual Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy subjects and subjects with primary / relapsed lung cancer
Criteria

Inclusion Criteria:

  • subjects ages 18 and above ICF obtain

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883388


Locations
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Israel
Rambam MC
Haifa, Israel, 31096
Sponsors and Collaborators
NovellusDx
Investigators
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Principal Investigator: Yishai Ofran, MD Rambam MC. Haematology Department
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Responsible Party: NovellusDx
ClinicalTrials.gov Identifier: NCT01883388    
Other Study ID Numbers: RAM-NOVEL-211-2012
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: October 2014
Keywords provided by NovellusDx:
Lung Cancer
blood sample
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases