An observational study in Gastrointestinal Tract Cancer and Peripheral Neuropathy, sponsored by Ain Shams University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Ain Shams University · Observational
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.
Pharmacogenetic analysis/genotyping :
Genotyping is conducted via High Resolution Melting (HRM) TECHNIQUE, To confirm the genotyping results, the Polymerase chain reaction (PCR) product of the samples will be examine via direct sequencing using 3500 Genetic analyzer from ThermoFisher (applied biosystem) at two ABCG2 loci using the following PCR primers:
1-ABCG2 G34A - rs2231137
Forward :
5'-TGC AAT CTC ATT TAT CTG GAC TA-'3
Reverse :
5'-AAT GCC TTC AGG TCA TTG GA-'3
-Annealing temp :57 -Product size : 163
2- ABCG2 A/A - rs3114018
Forward :
5'- TGATGTTCCTTCAGCCACTG-'3
Reverse :
5'-TTGTGGAAACCTCACAAAAGTG-'3
778 studies on the registry are indexed under Gastrointestinal Neoplasms; 230 are open to participants now.
This study's planned enrollment of 80 is below the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Patients with Gastrointestinal tract (GIT) Cancer
Exclusion Criteria:
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.
Time frame: After 6 cycles of chemotherapy (each cycle is15 days), for six months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Ain Shams University