Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Lung cancer is the leading cause of death worldwide, with non-small-cell lung cancer (NSCLC) being the most common histotype according to the global cancer observatory 2022. A variety of therapeutic options for advanced/metastatic non-oncogene-addicted NSCLC have recently been approved based on their impact on patient outcomes in terms of survival and safety profile. Current guidelines advocate for personalized treatment options based on molecular and immunologic characteristics, which drives the physician's decision toward tailored oncology. In the last two to three decades, hundreds of cancer biological prognostic markers for non-small cell lung cancer have been proposed. Although they have shown a potential in this ﬁeld, validation studies are still required and, to date, there is in suﬃcient evidence to recommend the routine clinical use of any of these putative biomarkers. Therefore, the discovery of robust prognostic and/or predictive biomarkers in patients with non-small cell lung cancer is imperative for advancing treatment strategies for the disease and improving patient care.

Official Title
-----------------
Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients

Conditions
-----------------
Non Small Cell Lung Cancer, Nephropathy, Cardiotoxicity

Intervention / Treatment
-----------------
* Drug: Cisplatin injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC cancer patients treated with Cisplatin-containing chemotherapy. Measurable disease. Age of 18 years to 80 years. Exclusion Criteria: Non-small cell lung cancer patients who had undergone radiotherapy or chemotherapy. Pregnant and lactating females. History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin. Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>NSCLC patients Who developed Toxicity to Chemotherapeutic agents | Drug: Cisplatin injection<br>* Cisplatin 75mg/m2<br>|
| 2<br>NSCLC patients Who did not developToxicity to Chemotherapeutic agents | Drug: Cisplatin injection<br>* Cisplatin 75mg/m2<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nephrotoxicity | Change in Creatinine Clearance | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood urea nitrogen | Change in Blood urea nitrogen | 6 months | 
| Serum creatinine | change in Serum creatinine | 6 month | 
| Cardiotoxicity | Change in ejection fraction | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung Cancer, Nephropathy, Cardiotoxicity, Gene polymorphism, Cisplatin