NCT04270851

Brief 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

February 12, 2020

Last Update Submit

February 12, 2020

Conditions

CancerCancer MetastaticColorectal CancerLiver Metastasis Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in decision making on technical resectability

    Liver surgeons will view the standard pre-operative assessment results and decide if each case scenario is 'technically resectable.' They will then view the results from these two additional pre-operative tests (LiMAx and HepaT1ca), and decide again. We will measure for any change in decision making after viewing the novel test results.

    One year

Secondary Outcomes (2)

  • Change in operative plan

    One Year

  • Level of agreement between liver surgeons on technical resectability

    One Year

Study Arms (1)

Borderline Resectability

Patients with colorectal liver metastases where the decision-making on technical resectability is difficult, i.e. 'borderline resectable,' where a group of liver surgeons might reasonably be expected to find the decision whether to operate to be challenging. A group of up to 20 such patients will undergo pre-operative LiMAx test and HepaT1ca pre-operative scanning. Recruited participants' data will be used to create anonymised online case scenarios to be used in a survey, assessing whether liver surgeons find these pre-operative assessments helpful in their decision-making on technical resectability.

Diagnostic Test: LiMAx testDiagnostic Test: HepaT1ca magnetic resonance scan

Interventions

LiMAx testDIAGNOSTIC_TEST

The LiMAx test is a fully licenced liver function test, testing liver maximum capacity via a breath test.

Borderline Resectability
HepaT1ca magnetic resonance scanDIAGNOSTIC_TEST

The HepaT1ca scan is a pre-operative magnetic resonance scan providing a detailed report permitting interactive virtual pre-operative planning prior to liver surgery.

Borderline Resectability

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases

You may qualify if:

  • Patients over 16 years of age with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases
  • Discussion at regional hepatobiliary multidisciplinary team meeting
  • Hepatobiliary surgical opinion that their case represents a potentially difficult decision regarding technical resectability
  • Ability to provide written informed consent

You may not qualify if:

  • Presence of a medical or psychiatric condition impairing the ability to give informed consent
  • Presence of any other serious uncontrolled medical condition
  • Patients under 16 years old
  • Contra-indications to magnetic resonance scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4NX, United Kingdom

Location

Related Publications (1)

  • Parmar KL, O'Reilly D, Valle J, Braun M, Malcomson L, Jones RP, Balaa F, Rees M, Welsh FKS, Filobbos R, Renehan AG. Protocol for the CoNoR Study: A prospective multi-step study of the potential added benefit of two novel assessment tools in colorectal liver metastases technical resectability decision-making. BMJ Open. 2023 Mar 30;13(3):e059369. doi: 10.1136/bmjopen-2021-059369.

    PMID: 36997247DERIVED

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

April 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)