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

Recruiting

• Conditions: Non Small Cell Lung Cancer; Nephropathy; Cardiotoxicity
• Interventions: Drug: Cisplatin injection

• Registration Number: NCT05746598
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-03-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Cisplatin injection	NSCLC patients Who developed Toxicity to Chemotherapeutic agents
2	Cisplatin injection	NSCLC patients Who did not developToxicity to Chemotherapeutic agents

Primary Outcome Measures

Name	Time	Method
Nephrotoxicity	6 months	Change in Creatinine Clearance

Secondary Outcome Measures

Name	Time	Method
Serum creatinine	6 month	change in Serum creatinine
Blood urea nitrogen	6 months	Change in Blood urea nitrogen
Cardiotoxicity	6 months	Change in ejection fraction

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt