Patients That Have Been Diagnosed With Colorectal CancerNCT01791322
NovellusDx Tissue Collection Protocol
An observational study of Patients That Have Been Diagnosed With Colorectal Cancer and Patients Eligible for Tumor Biopsy, run by Fore Biotherapeutics at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients That Have Been Diagnosed With Colorectal Cancer, Patients Eligible for Tumor Biopsy
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have been diagnosed with cancer and are eligible for tumor biopsy will be enrolled.
Who may be able to join
- Patients that have been diagnosed positive for colon cancer.
- available treatment follow up during cancer treatment
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Assess the Oncogenic Status of Colorectal Cancer Patients That Have Undergone Surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct identification of tumor mutant genes
Correct identification of tumor mutant genes, in over 85% of the cases
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients That Have Been Diagnosed With Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fore Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yakov Felig, Dr., Principal investigator, Pathology lab Hadassah MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791322
- Sponsor's protocol ID
- PM 01.1
- Status last verified
- Oct 2015
- First submitted
- 12 Feb 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Oncogenic Status of Colorectal Cancer Patients That Have Undergone Surgery
- ClinicalTrials.gov ID
- NCT01791322
- Acronym / sponsor ID
- PM 01.1
- Conditions
- Patients That Have Been Diagnosed With Colorectal Cancer, Patients Eligible for Tumor Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fore BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have been diagnosed with cancer and are eligible for tumor biopsy will be enrolled.
Key inclusion criteria (2 listed)
- Patients that have been diagnosed positive for colon cancer.
- available treatment follow up during cancer treatment
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correct identification of tumor mutant genes
Time frame: up to 12 month
Correct identification of tumor mutant genes, in over 85% of the cases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yakov Felig, Dr. principal investigator
Pathology lab Hadassah MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients That Have Been Diagnosed With Colorectal Cancer and Patients Eligible for Tumor Biopsy, run by Fore Biotherapeutics at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct identification of tumor mutant genes (time frame: up to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.