NovellusDx Functional Profiling of Oncogenic Mutations in Lung Cancer Patients

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02274025
• Lead Sponsor: Fore Biotherapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Status Verified: 2015-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Patients without lung cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correct identification of tumor mutant genes	up to 12 months	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.

Trial Locations

Locations (1)

Rabin Medical Center, Beilinson; 🇮🇱 Petah Tikva, Israel