NCT05273489

Brief Summary

Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2004

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

17 years

First QC Date

February 24, 2022

Last Update Submit

March 5, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recurrence

    Recurrence rate

    From surgery to recurrence, up to 16 years

  • Survival

    up to16 years

    From surgery to death or end of the study, up to 16 years

Secondary Outcomes (2)

  • Resection margins

    From surgery to death or end of the study, up to 16 years

  • Neoadjuvant Chemotherapy

    From surgery to death or end of the study, up to 16 years

Interventions

HepatectomyPROCEDURE

Neoadjuvant treatment

Also known as: Chemotherapy

Eligibility Criteria

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

Australian citizens (most of them locals) treated at The Queen Elizabeth Hospital, Adelaide, SA.

You may qualify if:

  • Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020

You may not qualify if:

  • Patients whose procedures were abandoned due to unresectable tumour burden

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

HepatectomyDrug Therapy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeTherapeutics

Study Officials

  • Mauro A Perdomo, MD, MHA

    Assitant Professor at Clinica Quirurgica 3. Universidad de la Republica. Monteviedo, Uruguay

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, General Surgeon

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 10, 2022

Study Start

January 1, 2004

Primary Completion

December 31, 2020

Study Completion

October 31, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Data could be provided on reasonable request