ClinicalTrials.gg
Status unknownNCT03791151Updated Jan 2, 2019

Pharmacogenetics in Non Small Cell Lung Cancer

An observational study in Non Small Cell Lung Cancer, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-02.

Sponsored by Ain Shams University · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

Study the effect of genetic polymorphism in the membrane copper transporter 1 protein [CTR1; encoded by the solute carrier family 31 member 1 gene (SLC31A1 gene)] and its genetic expression levels on the clinical outcome of cisplatin-based regimen used in the treatment of Non-Small Cell Lung Cancer (NSCLC) in terms of :

  • Treatment response : partial response (PR) / complete response (CR) and Progression-free survival (PFS)
  • Treatment resistance : stationary disease (SD) or progressed disease
  • Frequency and severity of regimen related toxicity
Read the detailed description

The cisplatin-based regimen is an effective treatment for advanced NSCLC, showing significant beneficial outcomes such as prolong survival, improve clinical symptoms, and improve quality of life (QOL) . Although platinum-based therapy shows several benefits, but the five-year survival rate still less than 20%.

Pt resistance is an inevitable occurrence with rare exception. Aside from germ cell tumors, metastatic solid tumors are generally thought to be incurable with cytotoxic chemotherapy due to the development of resistance and subsequent disease progression.

Despite the multifactorial nature of Cisplatin resistance, intracellular accumulation of Pt appears to be a major source of drug resistance . Reduced intracellular drug accumulation is one of the most consistently identified features of cisplatin-resistant cells.

Many evidences indicated that alteration of copper transporter protein 1 (CTR1) which is the major plasma membrane transporter responsible for platinum uptake, was associated with platinum sensitivity and toxicity.

Genetic polymorphisms of CTR1 also have effects to platinum treatment response. Therefore, CTR1 might be a potential prognostic factor for survival in cancer patients underwent chemotherapy and a treatment target for overcoming platinum resistance.

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Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Pharmacogenetics
  • Lung cancer
  • Cisplatin
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In context

Carcinoma, Non-Small-Cell Lung

6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 100 is below the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly diagnosed with immunohistochemically and pathologically confirmed non- small cell lung cancer (NSCLC).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Presence of central nervous system metastases.
  2. Inadequate liver function (bilirubin > 1.5 times upper normal limit [ULN] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3.0 ULN or up to 5.0 UNL in the presence of hepatic metastases).
  3. Inadequate renal function (creatinine > 1.25 times ULN, creatinine clearance \< 50mL/min).
  4. Serious comorbid systemic disorder incompatible with the study.
  5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
  6. Pregnancy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Tumor response and resistance

    will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the new Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Time frame: 1 year

Secondary outcomes

  1. Progression-free survival (PFS)

    defined as the time from day 1 of chemotherapy to the day of documented disease progression or death.

    Time frame: 1.5 years

  2. Regimen related toxicity

    1\. Hematologic toxicity (anemia, neutropenia, and thrombocytopenia) 2. Nephrotoxicity 3. Ototoxicity 4. Neurotoxicity

    Time frame: 1.5 years

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Study locations

1 of 1 sites recruiting
  • Ain Shams University's Hospital
    Cairo, 11566, Egypt
    Recruiting
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References and documents

Publications

  • Blair BG, Larson CA, Safaei R, Howell SB. Copper transporter 2 regulates the cellular accumulation and cytotoxicity of Cisplatin and Carboplatin. Clin Cancer Res. 2009 Jul 1;15(13):4312-21. doi: 10.1158/1078-0432.CCR-09-0311. Epub 2009 Jun 9. PubMed 19509135 ↗
  • Roco A, Cayun J, Contreras S, Stojanova J, Quinones L. Can pharmacogenetics explain efficacy and safety of cisplatin pharmacotherapy? Front Genet. 2014 Nov 14;5:391. doi: 10.3389/fgene.2014.00391. eCollection 2014. PubMed 25452763 ↗
  • Xu X, Ren H, Zhou B, Zhao Y, Yuan R, Ma R, Zhou H, Liu Z. Prediction of copper transport protein 1 (CTR1) genotype on severe cisplatin induced toxicity in non-small cell lung cancer (NSCLC) patients. Lung Cancer. 2012 Aug;77(2):438-42. doi: 10.1016/j.lungcan.2012.03.023. Epub 2012 Apr 17. PubMed 22516052 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03791151
Responsible party
Yara Sayed Abdulwahid (Clinical Pharmacist, Ain Shams University) — Principal investigator
First posted
Jan 2, 2019
Start date
Nov 1, 2018
Primary completion
Nov 30, 2019 (estimated)
Completion
Nov 30, 2019 (estimated)
Last update
Jan 2, 2019

Study contacts

Yara Sayed
Contact
yara.awes@gmail.com
01067004796 ext. +2

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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