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OpenTrials
Completed

NCT Number: NCT05093023

ABCB1 SNPs as Predictors of PIPN

The study aim is to determine the allele frequencies of 1236 G>A and 3435 G>A in ABCB1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in Egyptian patients. Additionally, the study aimed at fitting and validating logistic regression models with the aforementioned SNPs evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.

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Key information

Conditions

Paclitaxel Adverse Reaction Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuritis Neuromuscular Diseases Neuropathy;Peripheral Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Nasser's Institute Hospital

Cairo, Aghakhan, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Egyptian females ≥18 years of age.
  • Histologically confirmed Breast Cancer.
  • Receiving conventional neoadjuvant or adjuvant weekly paclitaxel.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (UNL), total bilirubin ≤1.5x UNL, absolute neutrophil count ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, AST and ALT ≤3.0x UNL, and alkaline phosphatase ≤3.0x UNL).
  • No major neurological disease or symptoms prior to the start of paclitaxel therapy.
  • neither subjective nor objective evidence of metastatic disease.

Exclusion criteria

  • Pregnancy.
  • Patients with recurrent or metastatic (local or distant) breast cancer.
  • Neuropathic at the time of recruitment.
  • History of neuropathy prior to recruitment.
  • Previously exposed to taxanes or any other microtubule Inhibitors, or regimens including platinates.
  • Patients currently receiving dose-dense biweekly taxane-containing regimens.

Treatment and study plan

Real-Time PCR

Genetic

Genomic DNA was extracted from 2 ml of venous blood. ABCB1 1236 G>A and 3435 G>A were genotyped using predesigned TaqMan SNP genotyping assays on a stepOne PCR instrument in accordance with the manufacturer's protocol.

Primary outcomes

  1. Grade 2 or higher peripheral neuropathy

    Time frame: 12 weeks

    Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

ABCB1 Single Nucleotide Polymorphism Genotypes as Predictors of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2021
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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