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

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer Nephropathy Cardiotoxicity

Keywords

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Non-small cell lung Cancer Nephropathy Cardiotoxicity Gene polymorphism Cisplatin

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

NSCLC patients Who developed Toxicity to Chemotherapeutic agents

Cisplatin injection

Intervention Type DRUG

Cisplatin 75mg/m2

2

NSCLC patients Who did not developToxicity to Chemotherapeutic agents

Cisplatin injection

Intervention Type DRUG

Cisplatin 75mg/m2

Interventions

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Cisplatin injection

Cisplatin 75mg/m2

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Misr International University

OTHER

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Neven Sarhan

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Neven Sarhan, PhD

Role: CONTACT

Phone: +201021944422

Email: [email protected]

Mona Schaalan, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Neven Sarhan, PhD

Role: primary

Other Identifiers

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NSCLC-Genetics

Identifier Type: -

Identifier Source: org_study_id