NCT01883388

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

March 29, 2018

Status Verified

October 1, 2014

Enrollment Period

3.5 years

First QC Date

June 17, 2013

Last Update Submit

March 27, 2018

Conditions

Lung Cancer

Keywords

Lung Cancerblood sample

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with a significant cancer fingerprint as measured by NovellusDX Cancer Early Detection test

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy subjects and subjects with primary / relapsed lung cancer

You may qualify if:

  • subjects ages 18 and above ICF obtain

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam MC

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yishai Ofran, MD

    Rambam MC. Haematology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Last Updated

March 29, 2018

Record last verified: 2014-10

Locations

IL(1)