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

February 16, 2023 updated by: Neven Sarhan, Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11315
        • Recruiting
        • Ain shams university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

• NSCLC cancer patients treated with Cisplatin-containing chemotherapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
NSCLC patients Who developed Toxicity to Chemotherapeutic agents
Drug: Cisplatin injection
Cisplatin 75mg/m2
2
NSCLC patients Who did not developToxicity to Chemotherapeutic agents
Drug: Cisplatin injection
Cisplatin 75mg/m2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Misr International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Estimate)

February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSCLC-Genetics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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