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Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin Toxicity and Disease Response to Treatment With Erbitux Requirements
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.
Baseline assessment: * Contact Lenses * Medical History * Previous chemotherapy * Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure) * Symptom Assessment (Pre-existing skin and/or eye conditions, CEA measurement (CRC only), Disease status (TNM Staging)) * Planned chemotherapy regimen * Radiotherapy Blood Sample: A 2ml blood sample should be collected in ethylenediamine-tetraacetic acid (EDTA) containing Vacutainer at any time before or after starting treatment. DNA will be extracted from the samples and the 11 SNPs in the region of the EGFR gene encoding domain III will be characterized. Follow-up Assessment: with every second cycle of Cetuximab- or Panitumumab-containing regimen (CRC: every 2. Week; NSCLC: every 3-4 weeks): * Visit Number and Date * Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure) * Symptom Assessment (CEA measurement (CRC only), Disease status (TMN Staging), Skin Toxicity (CTCAE) grading) * Current chemotherapy regimen * Radiotherapy * CEA measurement only for CRC (every second cycle/every 4 weeks) Long-term follow-up (up to 5 years): * CT restaging (TNM Staging) should be done 3 monthly for as long as the subject is receiving Cetuximab- or Panitumumab- containing regimen or if there is suspicion of disease progression. * OS
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Letterkenny General Hospital
Letterkenny, Donegal, Ireland
Bon Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
St Vincent's University Hospital
Dublin, Ireland
Mater Misericordiae University Hospital
Dublin, 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
Start Date
May 1, 2011
Primary Completion Date
May 11, 2021
Completion Date
May 11, 2021
Last Updated
July 8, 2025
161
ACTUAL participants
Lead Sponsor
Cancer Trials Ireland
NCT06305754
NCT06696768
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