Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04581967
Status:
UNKNOWN
Last Update Posted:
2020-10-09
First Post:
2020-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CYP2C19 and ALDH3A1 Polymorphisms in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}, {'id': 'D020641', 'term': 'Polymorphism, Single Nucleotide'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D011110', 'term': 'Polymorphism, Genetic'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA extract by extraction kits from whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients', 'timeFrame': 'Up to 24 weeks', 'description': 'the blood samples will be DNA extracted using DNA extraction kit then single nucleotide polymorphisms of CYP2C19 gene will be detected by real time PCR'}, {'measure': 'The frequency of the genetic polymorphisms of ALDH3A1 in breast cancer patients', 'timeFrame': 'Up to 24 weeks', 'description': 'the blood samples will be DNA extracted by DNA extraction kit then single nucleotide polymorphisms of ALDH3A1 gene will be detected by real time PCR'}], 'secondaryOutcomes': [{'measure': 'Correlation between genetic polymorphisms of CYP2C19 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy', 'timeFrame': 'up to 24 weeks', 'description': 'the blood samples will be DNA extracted using DNA extraction kit then single nucleotide polymorphisms of CYP2C19 gene will be detected by real time PCR'}, {'measure': 'Correlation between genetic polymorphisms of ALDH3A1 and toxicities from Doxorubicin-Cyclophosphamide regimen therapy', 'timeFrame': 'up to 24 weeks', 'description': 'the blood samples will be DNA extracted by DNA extraction kit then single nucleotide polymorphisms of ALDH3A1 gene will be detected by real time PCR'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Patients']}, 'referencesModule': {'references': [{'pmid': '22247839', 'type': 'BACKGROUND', 'citation': 'Sharma GN, Dave R, Sanadya J, Sharma P, Sharma KK. Various types and management of breast cancer: an overview. J Adv Pharm Technol Res. 2010 Apr;1(2):109-26.'}, {'pmid': '29507678', 'type': 'BACKGROUND', 'citation': 'Tecza K, Pamula-Pilat J, Lanuszewska J, Butkiewicz D, Grzybowska E. Pharmacogenetics of toxicity of 5-fluorouracil, doxorubicin and cyclophosphamide chemotherapy in breast cancer patients. Oncotarget. 2018 Jan 10;9(10):9114-9136. doi: 10.18632/oncotarget.24148. eCollection 2018 Feb 6.'}, {'pmid': '17135639', 'type': 'BACKGROUND', 'citation': "Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006 Dec 1;24(34):5381-7. doi: 10.1200/JCO.2006.06.5391."}, {'pmid': '23629563', 'type': 'BACKGROUND', 'citation': 'Montoya JE, Luna HG, Morelos AB, Catedral MM, Lava AL, Amparo JR, Cristal-Luna GR. Association of creatinine clearance with neutropenia in breast cancer patients undergoing chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide (FAC). Med J Malaysia. 2013 Apr;68(2):153-6.'}, {'pmid': '20179710', 'type': 'BACKGROUND', 'citation': 'Bray J, Sludden J, Griffin MJ, Cole M, Verrill M, Jamieson D, Boddy AV. Influence of pharmacogenetics on response and toxicity in breast cancer patients treated with doxorubicin and cyclophosphamide. Br J Cancer. 2010 Mar 16;102(6):1003-9. doi: 10.1038/sj.bjc.6605587. Epub 2010 Feb 23.'}, {'pmid': '29242966', 'type': 'BACKGROUND', 'citation': 'Zhou X, Qiao G, Wang X, Song Q, Morse MA, Hobeika A, Gwin WR, Ren J, Lyerly HK. CYP1A1 genetic polymorphism is a promising predictor to improve chemotherapy effects in patients with metastatic breast cancer treated with docetaxel plus thiotepa vs. docetaxel plus capecitabine. Cancer Chemother Pharmacol. 2018 Feb;81(2):365-372. doi: 10.1007/s00280-017-3500-9. Epub 2017 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'Genetic polymorphisms of metabolic enzymes may influence the metabolism of Doxorubicin-Cyclophosphamide regimen in breast cancer patients.\n\nthe investigators want to\n\n1. evaluate the frequency or incidence of the genetic polymorphisms of CYP2C19 and ALDH3A1 in breast cancer patients, and\n2. analyze the association between the genetic polymorphisms of CYP2C19 and ALDH3A1 and toxicities in breast cancer patients treated by Doxorubicin-Cyclophosphamide regimen therapy.', 'detailedDescription': "Breast cancer refers to the erratic growth and proliferation of cells that originate in the breast tissue, most commonly from the inner lining of milk ducts (ductal cancers) or the lobules that supply the ducts with milk (lobular cancers). Breast cancer is about 100 times more common in women than in men, although males tend to have poorer outcomes due to delays in diagnosis. Alteration in hormonal level and Family history of breast cancer are risk factors for breast cancer.\n\nThe classic symptom for breast cancer is a lump found in the breast or armpit. Doing monthly breast self-exam (BSE) is a great way to be familiar with the breasts' texture, cyclical changes, size, and skin condition. Breast cancer is usually diagnosed by biopsy of nodule detected by mammogram or by palpitation.\n\nToday there are so many approaches, which can be made for the treatment of breast cancer such as surgery, radiation therapy, chemotherapy, hormonal therapy and recently nanotechnology and gene therapy. Chemotherapy is the use of anti-cancer drugs to treat cancerous cells. The differences in patients' response to the same medication, toxicity included, are one of the major problems in breast cancer treatment.\n\nChemotherapy toxicity makes a significant clinical problem due to decreased quality of life, prolongation of treatment and reinforcement of negative emotions associated with therapy. Four cycles of doxorubicin and cyclophosphamide (AC) chemotherapy regimen has become a standard regimen. No chemotherapy regimen administered for four cycles has proven to be superior to AC. The undeniable advantage of this therapy scheme is low cost of treatment, its proven efficacy and mostly acceptable toxicity. Hematological (neutropenia and anemia) and gastrointestinal (nausea, vomiting and mucositis) toxicities are common in patients treated with AC regimen.\n\nDoxorubicin is metabolized by the CBR (carbonyl reductase) enzymes to its active component. Similarly cyclophosphamide, the cell cycle nonspecific prodrug, requires activation by a number of different cytochrome P450 enzymes, mainly of CYP2C family. The transport systems are also crucial for the treatment outcome, as both importers and exporters are responsible for the cellular drugs' concentration. It is expected that any variation that affects metabolic enzymes and transporter activity would be reflected in not only the response to treatment, but also in the development of drug-related toxicity. Each of these enzymes and transporter genes is known to exhibit a degree of genetic variation, characterized by single nucleotide polymorphisms (SNPs). In particular, there have been few investigations of the possible influence of variations in the genes encoding transporters and drug metabolizing enzymes relevant for the two drugs.\n\nPharmacogenomic analysis offers the promise that personalized regimens may be identified for individuals who might have more favorable outcomes with certain chemotherapies. Specifically, because genetic variation in metabolic enzymes is one determinant of drug concentration, pharmacogenomics has been proposed as an approach to tailor drug choice or dose to optimize efficacy and reduce toxicity of cancer treatments."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all breast cancer patients receiving either adjuvant or neoadjuvant therapy in National Cancer Institute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed diagnosis of breast cancer.\n2. Age ranging from 18 to 75 years old female.\n3. Patients will take Doxorubicin-Cyclophosphamide regimen as chemotherapy treatment.\n\nExclusion Criteria:\n\n1. Any other malignancy.\n2. Previous treatment for metastatic disease.\n3. Pregnancy or breastfeeding female.\n4. Inadequate bone marrow and cardiac function.\n5. Serious or uncontrolled medical conditions.'}, 'identificationModule': {'nctId': 'NCT04581967', 'briefTitle': 'Study of CYP2C19 and ALDH3A1 Polymorphisms in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Damanhour University'}, 'officialTitle': 'Pharmacogenetic Risk Factors of Doxorubicin-Cyclophosphamide Chemotherapy Related Toxicities in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '201819010.4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'polymorphism analysis', 'type': 'GENETIC', 'otherNames': ['single nucleotide polymorphism'], 'description': '* DNA will be purified from whole blood samples by commercial DNA isolation kits.\n* Genotyping and genetic polymorphism detection for some metabolic enzymes genes will be performed by real time PCR.'}, {'name': 'Doxorubicin-Cyclophosphamide regimen', 'type': 'DRUG', 'otherNames': ['chemotherapy treatment'], 'description': 'Treatment with a combination of Doxorubicin and Cyclophosphamide, This regimen comprises 60 mg/m² Doxorubicin and 600 mg/m² Cyclophosphamide administered intravenously on day 1 of each 21-day cycle, and repeated for a total of four cycles.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Marwa Nabeel, Ass. Prof', 'role': 'CONTACT', 'email': 'Marwa_nabil_25@yahoo.com', 'phone': '00201278511006'}, {'name': 'Esraa Khaled, B. Pharm', 'role': 'CONTACT', 'email': 'Esraakhaled11@gmail.com', 'phone': '00201009956676'}], 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hoda Salem, Ass. Prof', 'role': 'CONTACT', 'email': 'hsalem@ut.edu.sa', 'phone': '00201000007613'}, {'name': 'Esraa Khaled, B. Pharm', 'role': 'CONTACT', 'email': 'esraakhaled11@gmail.com', 'phone': '00201009956676'}], 'overallOfficials': [{'name': 'Hoda Salem, Ass. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of pharmacy, Al-Azhar university'}, {'name': 'Marwa Nabeel, Ass. Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute-Cairo University'}, {'name': 'Amira Bisheer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of pharmacy, Damanhour University'}, {'name': 'Esraa Khaled, B. Pharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of pharmacy, Al-Azhar University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}, {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Amira Bisher,PhD', 'investigatorAffiliation': 'Damanhour University'}}}}