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Trial Title:
the Effect of ABCC2 Genetic Polymorphism on Neurotoxicity in Gastrointestinal Cancer Patients Receiving Oxaliplatin
NCT ID:
NCT05494320
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Neurotoxicity Syndromes
Conditions: Keywords:
neurotoxicity
oxaliplatin
genetic polymorphism
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Folfox Protocol
Description:
Folfox: It includes the drugs leucovorin calcium (folinic acid), fluorouracil, and
oxaliplatin.
Other name:
Folfox_6
Summary:
Study the effect of genetic polymorphism (rs1885301, rs4148396 and rs3740066) in the
membrane of Multidrug resistance protein 2 (MRP2) encoded by ATP-binding cassette C2
(ABCC2) gene and its genetic expression levels on neurotoxicity in gasrtointestinal
cancer patients reciving Oxaliplatin-based chemotherapy.
Detailed description:
Several solutes carriers and ATP-binding cassette transporters have been implicated in
the influx or efflux of platinum-based chemotherapeutic agents such as cisplatin,
carboplatin, and oxaliplatin. The ATP-binding cassette (ABC-) transporter superfamily
contains several family members that may confer intrinsic or acquired multidrug
resistance (MDR) by extruding anticancer agents or their metabolites from cells and
suppression of such transporters may lead to sensitisation to cytostatic agents.
Multidrug resistance protein 2 (MRP2), encoded by the ATP-binding cassette C2 (ABCC2)
gene , is an efflux pump located on the apical membrane of many polarized cells, which
transports conjugate compounds by an ATP-dependent mechanism like oxaliplatin. Single
nucleotide polymorphisms (SNPs) in genes involved in drug transport like ABCC2 gene may
lead to higher intracellular oxaliplatin accumulation in the dorsal root ganglia and thus
increased risk of Oxaliplatin-induced peripheral neurotoxicity (OXPN). Enhanced ABCC2
expression can lead to decreased cellular glutathione content. Glutathione is needed for
oxaliplatin detoxification via conjugation, and it was reported that low glutathione
intra- cellular levels can cause increased oxaliplatin cytotoxicity. Moreover, ABCC2
mediates the export of the oxaliplatin-glutathione conjugated form, and ABCC2
overexpressing cells were resistant to platinum derivatives.
Criteria for eligibility:
Study pop:
All the pateints presenting to the department of Clinical Oncology Department, Ain Shams
University Hospitals with gastrointestinal cancer (stage ≥ stages II ) who receive
Oxaliplatin based chemotherapy ( FOLFOX6 ) for adjuvant and metastatic setting.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. gastrointestinal cancer Patients ( ≥ stages II ) who receive Oxaliplatin based
chemotherapy ( FOLFOX6 ) for adjuvant and metastatic setting.
2. Eastern Cooperative Oncology Group ( ECOG ) performance ≤ 2.
3. Adequate bone marrow functions ,liver functions and renal functions.
Exclusion Criteria:
1. Patients who have any clinical neuropathy.
2. Pateints with Diabetes mellitus.
3. Serious comorbid systemic disorder incompatible with study.
4. Pregnancy.
5. Other primary tumors.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ain shams university
Address:
City:
Cairo
Zip:
11566
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Sara Mohamed Abdel Aziz
Phone:
00201119215516
Email:
dr.sara.mohamed75@gmail.com
Start date:
August 15, 2021
Completion date:
December 31, 2022
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494320
