NCT01791322

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 29, 2018

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

February 12, 2013

Last Update Submit

March 27, 2018

Conditions

Patients That Have Been Diagnosed With Colorectal CancerPatients Eligible for Tumor Biopsy

Outcome Measures

Primary Outcomes (1)

  • Correct identification of tumor mutant genes

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

    up to 12 month

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that have been diagnosed with cancer and are eligible for tumor biopsy will be enrolled.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pathology Lab Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

pathology samples of tissue

Study Officials

  • Yakov Felig, Dr.

    Pathology lab Hadassah MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 13, 2013

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 29, 2018

Record last verified: 2015-10

Locations

IL(1)