NovellusDx Functional Profiling of Oncogenic Mutations in Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Collection of Lung Malignant Tissue for the Validation of a Novel Technology to Identify Oncogenic Mutations and Personalized Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274025
• Other study ID #: TISS001
• Status: Completed
• First received: October 14, 2014
• Last updated: March 27, 2018
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2015
• Source: NovellusDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson	Petah Tikva

Sponsors (2)

Lead Sponsor	Collaborator
NovellusDx	Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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