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CompletedNCT01791322Updated Mar 29, 2018

NovellusDx Tissue Collection Protocol

An observational study in Patients That Have Been Diagnosed With Colorectal Cancer and Patients Eligible for Tumor Biopsy, 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
15
Ages
18 Years to 85 Years
Sex
All
01

Study summary

NovellusDx is developing a diagnostic platform for the personalized cancer therapy based on patient derived tumor tissue. The assay is able to sense activating mutations by monitoring their effect on a chip-based device.

02

Conditions studied

  • Patients That Have Been Diagnosed With Colorectal Cancer
  • Patients Eligible for Tumor Biopsy
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 have been diagnosed with cancer and are eligible for tumor biopsy will be enrolled.

Inclusion criteria

  • Patients that have been diagnosed positive for colon cancer.
  • available treatment follow up during cancer treatment

Exclusion criteria

Exclusion Criteria:

  • None
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

  1. Correct identification of tumor mutant genes

    Correct identification of tumor mutant genes, in over 85% of the cases

    Time frame: up to 12 month

06

Study locations

1 site
  • Pathology Lab Hadassah Medical Center
    Jerusalem, 91120, Israel
07

Registry details

Key details

Study ID
NCT01791322
Lead sponsor
Fore Biotherapeutics
Responsible party
Sponsor
First posted
Feb 13, 2013
Start date
Jan 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Mar 29, 2018

Study contacts

Yakov Felig, Dr.
principal investigator · Pathology lab Hadassah MC

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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