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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05746598
Other study ID # NSCLC-Genetics
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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