Effect of Genetic Polymorphisms on Platinum Based Chemotherapy in Non Small Cell Lung Cancer

May 13, 2017 updated by: Esraa Salah Abdal Hay Abdal Khalek, Ain Shams University

Effect of Genetic Polymorphisms on Clinical Outcome of Platinum Based Chemotherapy in Non-Small Cell Lung Cancer Patients

This Study evaluate the effect of Polymorphism in the Excision repair cross-complementing group 5 (ERCC5) (rs1047768 and rs751402) gene on the clinical outcome of Platinum-based regimens used in the treatment of Non-Small Cell Lung Cancer (NSCLC) patients

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Al Demerdash Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

clinical oncology department at Al Demerdash hospital

Description

Inclusion Criteria:

  1. Newly diagnosed with immunohistochemically and pathologically confirmed non-small cell lung cancer (NSCLC).
  2. Eastern Cooperative Oncology Group performance status (ECOG PS) = 0-2.
  3. Chemotherapy naïve.
  4. Age >18 years.
  5. Adequate bone marrow reserve

Exclusion Criteria:

  1. Presence of Central nervous system(CNS) metastases.
  2. Inadequate liver function
  3. Inadequate renal function
  4. Serious comorbid systemic disorder incompatible with the study.
  5. Pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From the date of starting the chemotherapy until the date of documented disease progression or date of death from any cause assessed up to 12 months
It's defined as the time from day 1 of chemotherapy to the day of documented disease progression or death from any cause.
From the date of starting the chemotherapy until the date of documented disease progression or date of death from any cause assessed up to 12 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Esraa S Abdalkhalek, Ain Shams 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)

March 20, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 13, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 13, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHCL137

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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