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Trial Title:
Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients
NCT ID:
NCT05746598
Condition:
Non Small Cell Lung Cancer
Nephropathy
Cardiotoxicity
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Kidney Diseases
Cardiotoxicity
Cisplatin
Conditions: Keywords:
Non-small cell lung Cancer
Nephropathy
Cardiotoxicity
Gene polymorphism
Cisplatin
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Cisplatin injection
Description:
Cisplatin 75mg/m2
Arm group label:
1
Arm group label:
2
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.
Criteria for eligibility:
Study pop:
• NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Locations:
Facility:
Name:
Ain Shams University
Address:
City:
Cairo
Zip:
11315
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Neven Sarhan, PhD
Phone:
+201021944422
Email:
sarhanneven@gmail.com
Start date:
July 1, 2020
Completion date:
April 1, 2023
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Collaborator:
Agency:
Misr International University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746598
