Cancer Clinical Trial - Colorectal Liver Metastases: Novel Assessment

Status Not yet recruiting

Clinical Trial Summary

The CoNoR study aims to assess whether the use of the LiMAx test and the HepaT1ca pre-operative planning magnetic resonance scan impact upon technical resectability decision-making in colorectal liver metastases (CLM).

Clinical Trial Description

The CoNoR Study will occur via 4 workstreams:

1. Systematic review of all published criteria for colorectal liver metastases (CLM) technical resectability (systematic review protocol published on PROSPERO database: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=136748

2. Expert interviews: Interviews with liver surgeons and radiologists to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools

3. Online questionnaire: Online international questionnaire of liver surgeons to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools, in additional to identifying clinical scenarios in which these tools may be of greatest benefit

4. Online case-based survey: Recruitment of 10-20 participants with 'difficult decisions' regarding technical resectability, and consent to use results from pre-operative assessments to create anonymised online case-based survey. Participants will consent to have two additional pre-operative assessments: the LiMAx tests and the HepaT1ca magnetic resonance scan. These results from these additional tests will also be used in the online survey, We will recruit international liver surgeons to complete this online survey, where they will be asked to provide an opinion on technical resectability for each individual case scenario, and to specify their operative plan, both before and after seeing the results of these novel assessment tools. We will assess for change in decision-making on resectability, and change in operative plan after seeing these test results. We will also assess for level of agreement between liver surgeons on each scenario, and identify where they difficult decisions persist. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04270851
Study type	Observational
Source	University of Manchester
Contact
Status	Not yet recruiting
Phase
Start date	April 2020
Completion date	March 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability — CoNoR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms