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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
- Annealing temp : 59 - Product size : 124
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polymorphism analysis | Genetic |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Gastrointestinal tract (GIT) Cancer
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University hospitals | Cairo | Abbasia | Egypt |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| ID | Term |
|---|---|
| D016172 | DNA Fingerprinting |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
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| D005767 |
| Gastrointestinal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D021141 | Nucleic Acid Amplification Techniques |