NCT02274025

Brief Summary

NovellusDx technology identifies tumor-specific driver mutations, but unlike sequencing-based tests, NovellusDx has a functional assay that detects dis-regulated translocation of mutated signaling proteins to the nucleus. This allows NovellusDx to identify functionally-impactful driver mutations regardless of whether the mutation has previously been described or linked to a tumor type.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 29, 2018

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

October 14, 2014

Last Update Submit

March 27, 2018

Conditions

Lung Cancer

Keywords

Patient diagnosed with lung cancer

Outcome Measures

Primary Outcomes (1)

  • Correct identification of tumor mutant genes

    Correct identification of patient oncogenic mutation in over 85% of the cases. this will be achieved by comparing sequencing results of the patient tumors to the results achieved using the NovellusDx diagnostic platform.

    up to 12 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that are suspected to have lung cancer and are eligible for biopsy, surgical intervention or pleural fluid suction.

You may qualify if:

  • Patients that are suspected to have lung cancer and are eligible for biopsy, surgical intervention or pleural fluid suction

You may not qualify if:

  • Patients without lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson

Petah Tikva, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy material of patient or pleural fluids.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mordechai Kremer, Prof

    Rabin Medical Center, Beilinson

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 24, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 29, 2018

Record last verified: 2015-10

Locations

IL(1)