NCT03154242

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

May 9, 2017

Last Update Submit

May 13, 2017

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

non small cell lung cancerNSCLCPlatinum

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

clinical oncology department at Al Demerdash hospital

You may qualify if:

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

You may not qualify if:

  • Presence of Central nervous system(CNS) metastases.
  • Inadequate liver function
  • Inadequate renal function
  • Serious comorbid systemic disorder incompatible with the study.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Demerdash Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Esraa S Abdalkhalek

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

demonstrator of clinical pharmacy

CONTACT

01151958437esraa.salah@pharm.asu.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator of clinical pharmacy

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 16, 2017

Study Start

March 20, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

EG(1)