Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT05181202
Status:
UNKNOWN
Last Update Posted:
2022-01-06
First Post:
2021-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The predictive biomarkers of PLD induced hypersensitivity', 'timeFrame': '2022.06-2023.12', 'description': 'Detect and analyze the association between hypersensitivity and metabonomics, anti-PEG antibody, IgE et. al'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liposomal doxorubicin', 'hypersensitivity reaction', 'breast cancer'], 'conditions': ['Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients']}, 'referencesModule': {'references': [{'pmid': '9361959', 'type': 'BACKGROUND', 'citation': 'Alberts DS, Garcia DJ. Safety aspects of pegylated liposomal doxorubicin in patients with cancer. Drugs. 1997;54 Suppl 4:30-5. doi: 10.2165/00003495-199700544-00007.'}, {'pmid': '18502492', 'type': 'BACKGROUND', 'citation': 'Castells MC, Tennant NM, Sloane DE, Hsu FI, Barrett NA, Hong DI, Laidlaw TM, Legere HJ, Nallamshetty SN, Palis RI, Rao JJ, Berlin ST, Campos SM, Matulonis UA. Hypersensitivity reactions to chemotherapy: outcomes and safety of rapid desensitization in 413 cases. J Allergy Clin Immunol. 2008 Sep;122(3):574-80. doi: 10.1016/j.jaci.2008.02.044. Epub 2008 May 27.'}, {'pmid': '32142248', 'type': 'BACKGROUND', 'citation': 'Chen E, Chen BM, Su YC, Chang YC, Cheng TL, Barenholz Y, Roffler SR. Premature Drug Release from Polyethylene Glycol (PEG)-Coated Liposomal Doxorubicin via Formation of the Membrane Attack Complex. ACS Nano. 2020 Jul 28;14(7):7808-7822. doi: 10.1021/acsnano.9b07218. Epub 2020 Mar 6.'}, {'pmid': '32643376', 'type': 'BACKGROUND', 'citation': 'Gabizon A, Szebeni J. Complement Activation: A Potential Threat on the Safety of Poly(ethylene glycol)-Coated Nanomedicines. ACS Nano. 2020 Jul 28;14(7):7682-7688. doi: 10.1021/acsnano.0c03648. Epub 2020 Jul 9.'}, {'pmid': '25205349', 'type': 'BACKGROUND', 'citation': 'Verhoef JJ, Carpenter JF, Anchordoquy TJ, Schellekens H. Potential induction of anti-PEG antibodies and complement activation toward PEGylated therapeutics. Drug Discov Today. 2014 Dec;19(12):1945-52. doi: 10.1016/j.drudis.2014.08.015. Epub 2014 Sep 7.'}], 'seeAlsoLinks': [{'url': 'https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf', 'label': 'breast cancer epidemiology'}]}, 'descriptionModule': {'briefSummary': 'Pegylated liposomal doxorubicin (PLD) was an anthracycline nanomedicine to be approved for advanced breast cancer and other solid tumor therapy and showed a good disease control rate (57%). PLD could induce hypersensitivity reaction (HSR). There are about 9-25% patients got infusion reaction or HSR. Severe HSR could lead to allergic shock even presyncope or threat to life. To our knowledge, there were no sensitivity biomarker to predict the PLD induced HSR. And the mechanism of PLD induced HSR is unknown yet. Therefore, to analyze and discuss the biomarkers and mechanism of PLD induced HSR in advanced breast cancer, we design this prospective, observational, biomarker study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced breast cancer patients who recieve liposomal doxorubicin treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old; Breast cancer confirmed with histological or molecular diagnosis; Advanced breast cancer diagnosis according to American Joint Committee on cancer eighth edition cancer staging manual; Treatment with liposomal doxorubicin; No pregnancy plan and voluntary use of effective contraceptive measures during treatment\n\nExclusion Criteria:\n\n* Subjects who discontinued treatment due to previous severe adverse reactions to liposomal doxorubicin or doxorubicin; poor compliance.'}, 'identificationModule': {'nctId': 'NCT05181202', 'briefTitle': 'Biomarkers of Liposomal Doxorubicin Induced Hypersensitivity Reaction in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Biomarkers Study of Liposomal Doxorubicin Injection Induced Hypersensitivity Reaction in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'YDPLD191016-I1-SYSU-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypersensitivity reaction group', 'description': 'The patients get hypersensitivity after Pegylated liposomal doxorubicin injection.', 'interventionNames': ['Other: Blood sampling']}, {'label': 'None hypersensitivity reaction group', 'description': 'The patients do not get hypersensitivity after Pegylated liposomal doxorubicin injection.', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Collect blood before drug injection. we do not intervene the clinical administration or drug choice or other clinical treatment.', 'armGroupLabels': ['Hypersensitivity reaction group', 'None hypersensitivity reaction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanfang Ye, BM', 'role': 'CONTACT', 'email': 'sys_iit@163.com', 'phone': '+86-020-81336505'}], 'facility': 'Sun Yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wei Zhuang, Dr.', 'role': 'CONTACT', 'email': 'zhuangw8@mail.sysu.edu.cn', 'phone': '+86-13427526343'}, {'name': 'Suiwen Ye', 'role': 'CONTACT', 'phone': '+86-13825115916'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If we found a significant, sensitive biomarker of liposomal doxorubicin induced hypersensitivity, we will share the protocol and results with other scientists or clinical researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}