Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin and/or Eye Toxicity and Disease Response to Treatment With Cetuximab or Panitumumab - SNP and Cetuximab or Panitumumab Response
Baseline assessment:
- Karnofsky Performance status
- Presence of any pre-existing skin condition
- Routine haematology
- Biochemistry
- Carcinoembryonic Antigen (CEA) measurement
- Computed tomography (CT) imaging to assess baseline disease extent using TNM Staging
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 characterised.
Follow-up Assessment: with every second cycle of Cetuximab- or Panitumumab-containing
regimen (CRC: every 2. Week; NSCLC: every 3-4 weeks):
- Assessment of skin and eye toxicity using Common Terminology Criteria for Adverse
Events (CTCAE) version 4
- Haematology
- Biochemistry
- 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.
- TTP
- OS
Observational
Observational Model: Cohort, Time Perspective: Prospective
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
Yes
Ireland: Health Information and Quality Authority
ICORG 08-40
NCT01726309
May 2011
Name | Location |
---|