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Clinical Trials/NCT05746598
NCT05746598
Recruiting
Not Applicable

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

Ain Shams University1 site in 1 country178 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Cisplatin injection
Conditions
Non Small Cell Lung Cancer
Sponsor
Ain Shams University
Enrollment
178
Locations
1
Primary Endpoint
Nephrotoxicity
Status
Recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
April 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neven Sarhan

Lecturer

Misr International University

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.

Arms & Interventions

1

NSCLC patients Who developed Toxicity to Chemotherapeutic agents

Intervention: Cisplatin injection

2

NSCLC patients Who did not developToxicity to Chemotherapeutic agents

Intervention: Cisplatin injection

Outcomes

Primary Outcomes

Nephrotoxicity

Time Frame: 6 months

Change in Creatinine Clearance

Secondary Outcomes

  • Serum creatinine(6 month)
  • Blood urea nitrogen(6 months)
  • Cardiotoxicity(6 months)

Study Sites (1)

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