The study is aimed at patients with advanced cancer and EGFR mutation. Some molecules recently discovered at the level of tumor tissue can influence the response to anti-EGFR drugs. Among these molecules is NRG1, which binds to the EGFR receptor family.
Unravelling the mechanisms that give cancer cells resistance to such biologics could improve response to therapy and survival. And analyzing tumors during anti-EGFR drug therapy used in clinical practice could allow us to perform analyses on NRG1 and hypothesize a possible strategy to increase survival
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* patients aged ≥ 18 years
* patients with advanced cancer characterized by amplification/overexpression or activating mutations of the EGFR receptor.
* patients who are candidates for treatment with TKI and/or mAbs both in the first and second line, according to clinical practice.
* possibility of obtaining all information relating to the clinical history - obtaining written informed consent
Exclusion Criteria:
* Patients who in the opinion of the investigator may not be compliant with the needs of the study
* patients suffering from pathologies (e.g. psychiatric, neurological) that do not allow the obtaining of valid informed consent
Primary outcome measure(s)
To evaluate in vitro the molecular mechanisms that regulate the expression of NRG1 and/or IL-1 in relation to ERBB family receptors (EGFR, HER2, HER3 and HER4) before and after the standard therapy resistance phase in patients with mutation in — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months The expression of NRG1 and receptors of the ERBB family, pre- and post-treatment, and any receptors involved in resistance, including c-MET, IL-1R1, IL-1 and PD-L1, will be evaluated on tumor tissue. A qualitative and quantitative comparative evaluation of the expression of these genes between T0 and T2 will then be carried out.
The expression of some cytokines including IL-1 and NRG1, at the T0, T1 and T2 timepoints, will be assessed by ELISA on blood and effusions (ascites, pleural fluid).
Trial sites (1)
Facility
City
Region
Status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna
Italy
More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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