Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer

NCT02428101 | Unknown DMC

• 1 other identifier: master(No.38)
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine DNA from Gastrointestinal Tract of cancer patients treated with oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to drug-induced peripheral neuropathy in certain patients. The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2 single nucleotide polymorphism (G34A - rs2231137 and A/A -rs3114018 genotypes) and correlated with peripheral neuropathy grades.

Conditions

Gastrointestinal Tract Cancer; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Correlation of single nucleotide polymorphisms of ABCG2 gene (G34A - rs2231137 and A/A -rs3114018 genotypes) with peripheral neuropathy grades, using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE)

  Peripheral Neuropathy Toxicity will be assessed every cycle for six months using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE). Patients will be assigned to 4 groups according to the grades of neuropathy.

  After 6 cycles of chemotherapy (each cycle is15 days), for six months

Interventions

polymorphism analysis GENETIC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Gastrointestinal tract (GIT) Cancer

You may qualify if:

• Gastrointestinal Tract Cancer patients treated with Oxaliplatin-containing chemotherapy
• Measurable disease
• Age of 18 years to 80 years

You may not qualify if:

• Pregnant women
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oxaliplatin.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Neurologic disease or patients with disease impairing the neurologic function affecting

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Peripheral Nervous System Diseases

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Inas M Moukhtar Ahmed, B.pharma

  Faculty of Pharmacy, Ain Shams Universty

  PRINCIPAL INVESTIGATOR

• Lamia M El Wakeel, Assoc. Prof

  Clinical Pharmacy, Ain Shams University

  STUDY DIRECTOR

• Abdel Hady A Abdel Wahab, Professor

  Biochemistry & Molecular biology,Cairo University

  STUDY CHAIR

• Amr S Saad, Assoc. Prof

  Clinical Oncology, Ain Shams University

  STUDY CHAIR

• Raafat R Abdel-Malek, Assoc. Prof

  clinical oncology, cairo university

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: African Union,organization St. Abbsia, Cairo, Egypt

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: April 28, 2015
• Study Start: November 1, 2014
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

EG (1)