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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03154242
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):
Esraa Salah Abdal Hay Abdal Khalek, Ain Shams University

Brief Summary:
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

Condition or disease
Carcinoma, Non-Small-Cell Lung

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of Genetic Polymorphisms on Clinical Outcome of Platinum Based Chemotherapy in Non-Small Cell Lung Cancer Patients
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
clinical oncology department at Al Demerdash hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03154242

Contact: demonstrator of clinical pharmacy 01151958437

Al Demerdash Hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Principal Investigator: Esraa S Abdalkhalek Ain Shams University

Responsible Party: Esraa Salah Abdal Hay Abdal Khalek, demonstrator of clinical pharmacy, Ain Shams University Identifier: NCT03154242     History of Changes
Other Study ID Numbers: PHCL137
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Esraa Salah Abdal Hay Abdal Khalek, Ain Shams University:
non small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms