ClinicalTrials.gg
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

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fore Biotherapeutics is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients without lung cancer
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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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
06

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

07

Study locations

1 site
  • Rabin Medical Center, Beilinson
    Petah Tikva, Israel
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2014 to primary completion in Oct 2016, 24 months.

Of 90 industry-sponsored observational studies under Lung Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's 24 months is below that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2014
First posted
Oct 24, 2014
StartActual
Oct 2014
Primary completionActual
Oct 2016
CompletionActual
Oct 2016
Last update
Mar 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02274025
Lead sponsor
Fore Biotherapeutics
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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Discussion

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