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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746598
• Other study ID #: NSCLC-Genetics
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2023
• Source: Ain Shams University
• Contact: Neven Sarhan, PhD
• Phone: +201021944422
• Email: sarhanneven[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cardiotoxicity
• Kidney Diseases
• Lung Neoplasms
• Nephropathy
• Non Small Cell Lung Cancer

Intervention

Drug:
• Cisplatin injection
Cisplatin 75mg/m2

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nephrotoxicity	Change in Creatinine Clearance	6 months
Secondary	Blood urea nitrogen	Change in Blood urea nitrogen	6 months
Secondary	Serum creatinine	change in Serum creatinine	6 month
Secondary	Cardiotoxicity	Change in ejection fraction	6 months