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AREG, EREG and EGFR: Response to Anti-EGFR Agents in Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03986541
Recruitment Status : Suspended (COVID-19)
First Posted : June 14, 2019
Last Update Posted : March 30, 2020
Sponsor:
Collaborators:
University of Liverpool
University of Manchester
Newcastle University
University of Nottingham
University of Sheffield
Information provided by (Responsible Party):
Philip Quirke, University of Leeds

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.

Condition or disease Intervention/treatment
Colorectal Cancer Stage IV Diagnostic Test: Immunohistochemistry

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Study Type : Observational
Estimated Enrollment : 960 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Association Between Tumour Amphiregulin, Epiregulin and Epidermal Growth Factor Receptor (EGFR) Expression and Response to Anti-EGFR Agents in Colorectal Cancer
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Retrospective cohort
Patients with advanced colorectal cancer previously treated with an anti-EGFR agent (panitumumab or cetuximab).
Diagnostic Test: Immunohistochemistry
Assessment of tumour amphiregulin, epiregulin and EGFR expression by immunohistochemistry.

Prospective cohort
Patients with advanced colorectal cancer newly starting treatment with an anti-EGFR agent (panitumumab or cetuximab).
Diagnostic Test: Immunohistochemistry
Assessment of tumour amphiregulin, epiregulin and EGFR expression by immunohistochemistry.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: March 2023 ]
    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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: March 2023 ]
    OS will be determined from date of commencing treatment to death.

  2. Objective response rate [ Time Frame: 8-12 weeks post commencement of treatment ]
    ORR is the proportion of patients with documented radiological complete or partial response on first follow-up imaging.

  3. Disease control rate [ Time Frame: 8-12 weeks post commencement of treatment ]
    DCR is the proportion of patients with either radiologically stable disease or a response on first follow-up imaging


Biospecimen Retention:   Samples With DNA
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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986541


Locations
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United Kingdom
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, United Kingdom, L7 8XP
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S5 7AU
The Clatterbridge Cancer Centre
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
University of Leeds
University of Liverpool
University of Manchester
Newcastle University
University of Nottingham
University of Sheffield
Investigators
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Principal Investigator: Philip Quirke, PhD FRCPath University of Leeds - Institute of Medical Research at St James's
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Responsible Party: Philip Quirke, Professor Philip Quirke, University of Leeds
ClinicalTrials.gov Identifier: NCT03986541    
Other Study ID Numbers: N6AREG/EREG
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Quirke, University of Leeds:
colorectal cancer
anti-EGFR agents
cetuximab
panitumumab
amphiregulin
epiregulin
EGFR
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases