ABCB1 SNPs as Predictors of PIPN

October 13, 2021 updated by: nabil mahmoud, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

92

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
    • Aghakhan
      • Cairo, Aghakhan, Egypt
        • Nasser's Institute 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

Female

Sampling Method

Non-Probability Sample

Study Population

Egyptian women with histologically confirmed Breast Cancer, receiving neoadjuvant and/or adjuvant weekly paclitaxel-containing regimens.

Description

Inclusion Criteria:

  1. Egyptian females ≥18 years of age.
  2. Histologically confirmed Breast Cancer.
  3. Receiving conventional neoadjuvant or adjuvant weekly paclitaxel.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  5. 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).
  6. No major neurological disease or symptoms prior to the start of paclitaxel therapy.
  7. neither subjective nor objective evidence of metastatic disease.

Exclusion Criteria:

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

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
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)
12 weeks

Collaborators and Investigators

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

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCB1 in Paclitaxel Neuropathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Breast Cancer

Clinical Trials on Real-Time PCR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe