the Effect of ABCC2 Genetic Polymorphism on Neurotoxicity in Gastrointestinal Cancer Patients Receiving Oxaliplatin

NCT05494320 | Unknown

• 1 other identifier: 279
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Cancer

Keywords

neurotoxicity; oxaliplatin; genetic polymorphism

Outcome Measures

Primary Outcomes (1)

• neurotoxicity

  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 gastrointestinal cancer patients reciving Oxaliplatin-based chemotherapy. Grading of peripheral neuropathy using National Cancer Institute's Common Toxicity Criteria for Adverse Event ( NCI- CTCAE V5.0 ) will be assessed at baseline and before each cycle.

  6 months

Interventions

Folfox Protocol DRUG

Folfox: It includes the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.

Also known as: Folfox_6

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• gastrointestinal cancer Patients ( ≥ stages II ) who receive Oxaliplatin based chemotherapy ( FOLFOX6 ) for adjuvant and metastatic setting.
• Eastern Cooperative Oncology Group ( ECOG ) performance ≤ 2.
• Adequate bone marrow functions ,liver functions and renal functions.

You may not qualify if:

• Patients who have any clinical neuropathy.
• Pateints with Diabetes mellitus.
• Serious comorbid systemic disorder incompatible with study.
• Pregnancy.
• Other primary tumors.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Abassia, 11566, Egypt

RECRUITING

Related Publications (10)

• Alberti P, Rossi E, Cornblath DR, Merkies IS, Postma TJ, Frigeni B, Bruna J, Velasco R, Argyriou AA, Kalofonos HP, Psimaras D, Ricard D, Pace A, Galie E, Briani C, Dalla Torre C, Faber CG, Lalisang RI, Boogerd W, Brandsma D, Koeppen S, Hense J, Storey D, Kerrigan S, Schenone A, Fabbri S, Valsecchi MG, Cavaletti G; CI-PeriNomS Group. Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: two sides of the same coin. Ann Oncol. 2014 Jan;25(1):257-64. doi: 10.1093/annonc/mdt409. Epub 2013 Nov 19.

  PMID: 24256846 BACKGROUND

• Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.

  PMID: 19451431 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Cappell MS. Pathophysiology, clinical presentation, and management of colon cancer. Gastroenterol Clin North Am. 2008 Mar;37(1):1-24, v. doi: 10.1016/j.gtc.2007.12.002.

  PMID: 18313537 BACKGROUND

• Cecchin E, D'Andrea M, Lonardi S, Zanusso C, Pella N, Errante D, De Mattia E, Polesel J, Innocenti F, Toffoli G. A prospective validation pharmacogenomic study in the adjuvant setting of colorectal cancer patients treated with the 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX4) regimen. Pharmacogenomics J. 2013 Oct;13(5):403-9. doi: 10.1038/tpj.2012.31. Epub 2012 Aug 7.

  PMID: 22868256 BACKGROUND

• Ewertz M, Qvortrup C, Eckhoff L. Chemotherapy-induced peripheral neuropathy in patients treated with taxanes and platinum derivatives. Acta Oncol. 2015 May;54(5):587-91. doi: 10.3109/0284186X.2014.995775. Epub 2015 Mar 9.

  PMID: 25751757 BACKGROUND

• Grady WM, Markowitz SD. The molecular pathogenesis of colorectal cancer and its potential application to colorectal cancer screening. Dig Dis Sci. 2015 Mar;60(3):762-72. doi: 10.1007/s10620-014-3444-4. Epub 2014 Dec 10.

  PMID: 25492499 BACKGROUND

• Nichetti F, Falvella FS, Miceli R, Cheli S, Gaetano R, Fuca G, Infante G, Martinetti A, Antoniotti C, Falcone A, Di Bartolomeo M, Cremolini C, de Braud F, Pietrantonio F. Is a pharmacogenomic panel useful to estimate the risk of oxaliplatin-related neurotoxicity in colorectal cancer patients? Pharmacogenomics J. 2019 Oct;19(5):465-472. doi: 10.1038/s41397-019-0078-0. Epub 2019 Feb 4.

  PMID: 30713338 BACKGROUND

• Mirakhorli M, Rahman SA, Abdullah S, Vakili M, Rozafzon R, Khoshzaban A. Multidrug resistance protein 2 genetic polymorphism and colorectal cancer recurrence in patients receiving adjuvant FOLFOX-4 chemotherapy. Mol Med Rep. 2013 Feb;7(2):613-7. doi: 10.3892/mmr.2012.1226. Epub 2012 Dec 7.

  PMID: 23232902 BACKGROUND

• Nguyen TQ, Bui TO, Tran PT, Tran VT, Nguyen VH, Chu QH, Bui TAT, Le NQ, Le VQ, Dao VT. Modified Folfox6 as Adjuvant Chemotherapy in Vietnamese Patients With Colorectal Cancer. Cancer Control. 2019 Jan-Dec;26(1):1073274819864111. doi: 10.1177/1073274819864111.

  PMID: 31317770 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Neurotoxicity Syndromes

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Nagwa Ali Sabri, Professor

  Clinical Pharmacy Department - Faculty of Pharmacy - Ain Shams University

  STUDY DIRECTOR

• May Ahmed Shawki, Lecturer

  Clinical Pharmacy Department - Faculty of Pharmacy - Ain Shams University

  STUDY DIRECTOR

• Diaa Eldin Moussa Sherif, Lecturer

  Clinical oncology and nuclear medicine Department -Faculty of medicine-Ain Shams University

  STUDY DIRECTOR

• Sara Mohamed Abdel Aziz, Master Student

  Clinical Pharmacy Department - Faculty of Pharmacy - Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Mohamed Abdel Aziz, Master Student

CONTACT

00201119215516; dr.sara.mohamed75@gmail.com

May Ahmed Shawki, Lecturer

CONTACT

00201001701461; mannus.ahmed@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pharmacist

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: August 15, 2021
• Primary Completion: August 5, 2022
• Study Completion: December 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

EG (1)