A Study of Serum Protein Profiling in Patients With Non-Small Cell Lung Cancer Treated With Gefitinib or Erlotinib
We hypothesize that Epidermal growth factor receptor tyrosine kinase inhibitors modulate tumor changes that may be reflected in the alteration of serum proteins.
Study objectives are:
- To establish serum proteomic changes in patients with non-small cell lung cancer (NSCLC) receiving erlotinib or gefitinib.
- To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in NSCLC patients with and without EGFR mutations.
- To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Background:
Although some success has been achieved in identifying Epidermal growth factor receptor (EGFR) mutations as a molecular predictive marker of response in patients with non-small cell lung cancer (NSCLC), this strategy is likely only to be limited as not all responding patients have a mutation in their tumor and conversely, not all patients with a mutation were responders. Furthermore, as the development of resistance to EGFR tyrosine kinase inhibitors (TKI) such as gefitinib, erlotinib is inevitable and poses a major clinical problem due to limited therapeutic options, the identification of a molecular profile that could predict sensitivity to erlotinib or gefitinib is warranted.
Hypothesis:
Using serum as an easily accessible biological fluid, we hypothesize that EGFR TKIs modulate tumor changes that may be reflected in the alteration of serum proteins.
Objectives:
- To establish the serum proteomic changes in NSCLC patients receiving erlotinib or gefitinib.
- To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in NSCLC patients with and without EGFR mutations.
- To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.
Significance:
An extensive profiling of the molecular circuitry affected by EGFR TKIs would be helpful in understanding the response and side effects of patients with NSCLC treated with erlotinib or gefitinib and could guide therapy and thus improve patient outcome.
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Singapore, Singapore
- National University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Any patient with NSCLC receiving erlotinib or gefitinib.
- Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.
- Age ≥ 18 years
- Written informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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1
Any patient with NSCLC receiving erlotinib or gefitinib
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Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NS01/19/05
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