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CompletedNCT02274025Updated Mar 29, 2018

NovellusDx Functional Profiling of Oncogenic Mutations in Lung Cancer Patients

An observational study in Lung Cancer, sponsored by Fore Biotherapeutics. Completed at 1 site in Israel. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Fore Biotherapeutics · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer

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Keywords

  • Patient diagnosed with lung cancer
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients without lung cancer
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
05

What researchers measure

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.

    Time frame: up to 12 months

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Study locations

1 site
  • Rabin Medical Center, Beilinson
    Petah Tikva, Israel
07

Registry details

Key details

Study ID
NCT02274025
Lead sponsor
Fore Biotherapeutics
Collaborators
Rabin Medical Center
Responsible party
Sponsor
First posted
Oct 24, 2014
Start date
Oct 2014
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Mar 29, 2018

Study contacts

Mordechai Kremer, Prof
principal investigator · Rabin Medical Center, Beilinson

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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