Study Stopped
As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4
Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin Toxicity and Disease Response to Treatment With Erbitux Requirements
1 other identifier
observational
161
1 country
10
Brief Summary
Primary Objective: Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region. Secondary Objectives: Correlation of SNP profile with indicators of tumour response parameters, such as radiological response, duration of response, time to progression (TTP), overall survival (OS) time, incidence of non-dermatological adverse events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2011
Longer than P75 for all trials
10 active sites
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
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 9, 2012
CompletedFirst Posted
Study publicly available on registry
November 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2021
CompletedJuly 8, 2025
July 1, 2025
10 years
November 9, 2012
July 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between the type and degree of reported skin and/or eye reaction and the SNP profile of the EGFR domain III region.
Using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Throughout treatment with up to 5 years in follow up
Secondary Outcomes (1)
Correlation between the SNP profile(s) and disease response
Throughout treatment with up to 5 years in follow up
Study Arms (2)
Stage IV CRC
Stage IV NSCLC
Eligibility Criteria
Patient Population: 150 Patients with histologically proven stage IV (AJCC 7th Edition) colorectal cancer (CRC) expressing wild-type KRAS or stage IV non-small cell lung cancer (NSCLC) expressing EGFR (tested by immunohistochemistry (IHC)), with no previous exposure to Cetuximab or Panitumumab, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
You may qualify if:
- Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC with wild-type KRAS and not a candidate for metastasectomy.
- Stage IV (AJCC 7th Edition, TMN Staging, Appendix C) NSCLC expressing EGFR (IHC tested)
- Patients, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
- Karnofsky performance status (Appendix B) score ≥60.
- Acceptable laboratory values:
- Haemoglobin ≥ 9 g/dL.
- Neutrophil count ≥ 1.0 x 10\^9/L.
- Platelet count ≥100 x 10\^9/L.
- Serum creatinine ≤1.5 times the upper limit of normal.
- Bilirubin ≤1.5 times the upper limit of normal.
- Aspartate aminotransferase and alanine aminotransferase ≤5 times the upper limit of normal.
You may not qualify if:
- Aged \< 18 years
- Prior exposure to Cetuximab or Panitumumab
- The CRC does not carry wild-type KRAS.
- The NSCLC stains negative for EGFR protein expression
- Second cancer diagnosis (apart from non-melanoma skin cancer)
- Known hypersensitivity to Cetuximab or Panitumumab, or murine protein.
- Known history of coronary artery disease, arrhythmias, or congestive heart failure (If the treating physician feels that a patient's coronary artery disease / arrhythmia / congestive heart failure does not place him/her at risk from treatment with an anti-EGFR antibody, the person can be included. This is a clinical decision, which has to be made by the treating physician).
- Known to be pregnant (pregnancy test is not mandatory) or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Letterkenny General Hospital
Letterkenny, Donegal, Ireland
Bon Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
St Vincent's University Hospital
Dublin, 4, Ireland
Mater Misericordiae University Hospital
Dublin, 7, Ireland
Beaumont Hospital
Dublin, Ireland
The Adelaide & Meath Hosptal, Dublin Incorporating The National Children's Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Our Lady of Lourdes Hospital, Drogheda
Louth, Ireland
Waterford Regional Hospital
Waterford, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2012
First Posted
November 14, 2012
Study Start
May 1, 2011
Primary Completion
May 11, 2021
Study Completion
May 11, 2021
Last Updated
July 8, 2025
Record last verified: 2025-07