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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05746598
Enrollment
178
Registered
2023-02-28
Start date
2020-07-01
Completion date
2023-04-01
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Nephropathy, Non Small Cell Lung Cancer

Keywords

Non-small cell lung Cancer, Nephropathy, Cardiotoxicity, Gene polymorphism, Cisplatin

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.

Interventions

DRUGCisplatin injection

Cisplatin 75mg/m2

Sponsors

Misr International University
CollaboratorOTHER
Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Nephrotoxicity6 monthsChange in Creatinine Clearance

Secondary

MeasureTime frameDescription
Blood urea nitrogen6 monthsChange in Blood urea nitrogen
Serum creatinine6 monthchange in Serum creatinine
Cardiotoxicity6 monthsChange in ejection fraction

Countries

Egypt

Contacts

Primary ContactNeven Sarhan, PhD
sarhanneven@gmail.com+201021944422
Backup ContactMona Schaalan, PhD
mona.schaalan@miuegypt.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026