AREG, EREG and EGFR: Response to Anti-EGFR Agents in Colorectal Cancer
Association Between Tumour Amphiregulin, Epiregulin and Epidermal Growth Factor Receptor (EGFR) Expression and Response to Anti-EGFR Agents in Colorectal Cancer
1 other identifier
observational
541
1 country
7
Brief Summary
Observational study investigating the relationship between tumour amphiregulin, epiregulin and epithelial growth factor receptor expression and response to anti-EGFR agents in advanced colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2022
CompletedMay 28, 2024
May 1, 2024
2.4 years
June 13, 2019
May 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
PFS will be calculated from date of commencing treatment to date of progression or death from any cause (whichever is sooner). Time of progression will be determined clinically or radiologically by the participant's treating oncologist.
March 2023
Secondary Outcomes (3)
Overall survival
March 2023
Objective response rate
8-12 weeks post commencement of treatment
Disease control rate
8-12 weeks post commencement of treatment
Study Arms (2)
Retrospective cohort
Patients with advanced colorectal cancer previously treated with an anti-EGFR agent (panitumumab or cetuximab).
Prospective cohort
Patients with advanced colorectal cancer newly starting treatment with an anti-EGFR agent (panitumumab or cetuximab).
Interventions
Assessment of tumour amphiregulin, epiregulin and EGFR expression by immunohistochemistry.
Eligibility Criteria
Patients with RAS-wt aCRC who received or are receiving standard care palliative treatment with an anti-EGFR agent and chemotherapy of physician's choice. Within the retrospective cohort, patients who received single agent anti-EGFR therapy under previous Cancer Drugs Fund criteria will be accepted.
You may qualify if:
- Biopsy proven advanced colorectal adenocarcinoma at time treatment commenced (either inoperable metastatic disease at diagnosis or inoperable recurrent disease)
- Aged 18 or over at time treatment commenced
- The patient has received or has consented to receive treatment with cetuximab or panitumumab
You may not qualify if:
- Stage I, II or III colorectal adenocarcinoma
- RAS mutant disease
- Eligible for potentially curative surgery (prospective cohort)
- Underwent cancer surgery subsequent to anti-EGFR therapy (retrospective cohort)
- Unable to provide informed consent (with the exception of patients in the retrospective cohort who have passed away)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- University of Liverpoolcollaborator
- University of Manchestercollaborator
- Newcastle Universitycollaborator
- University of Nottinghamcollaborator
- University of Sheffieldcollaborator
Study Sites (7)
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, West Yorkshire, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU, United Kingdom
Biospecimen
Consent sought for retention of pathological specimens of colorectal cancer for future Research Ethics Committee approved bowel cancer research (not a prerequisite to study participation)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Quirke, PhD FRCPath
University of Leeds - Institute of Medical Research at St James's
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Philip Quirke
Study Record Dates
First Submitted
June 13, 2019
First Posted
June 14, 2019
Study Start
September 23, 2019
Primary Completion
February 22, 2022
Study Completion
July 22, 2022
Last Updated
May 28, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share