Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-12 @ 11:04 AM
Study NCT ID:
NCT04778202
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic and Prognostic Value of MicroRNA in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample by veinpuncture prosedure into EDITA tubes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of the value of MiRNA in diagnosis and prognosis of breast cancer patients', 'timeFrame': '18-24 month', 'description': 'To evaluate diagnostic and prognostic role of MiRNA 125a-5p and 143-3p as a non invasive biomarker in breast cancer'}, {'measure': 'correlat MiRNA expression with MRI findings for better selection of treatment plan and out come', 'timeFrame': '18-24 months', 'description': 'Also trying to correlate the results with MRI radiological findings which may help in better selection of treatment protocols.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30207593', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of miRNA 125a -5p and miRNA143-3p as a non invasive biomarker in diagnosis of breast cancer and the relationship between MiRNA expression and histopathological features as tumor stage ,grade ,molecular subtypes. Also trying to correlate the results with MRI radiological findings which may help in better selection of treatment protocols.', 'detailedDescription': "Breast cancer ( BC) is the most commonly diagnosed cancer in women worldwide. The incidence and mortality rates for female breast cancer far exceeded those for other cancers . Although the incidence rate of breast cancer has risen, the mortality rates have steadily fallen due to early diagnosis and better treatments . Early detection of breast cancer often leads to better outcomes. According to Cancer Australia's National Cancer Control Indicators, the relative survival for females diagnosed with early-stage breast cancers at diagnosis was much higher than that for those with advanced breast diagnosis.\n\nDespite the improvement in diagnosis and treatment,approximately 20% of BC patients will develop metastasis.This setting is considered an incurable disease that often occurs due to either resistance to therapy or diagnosis at advanced stages . In this scenario, although 44% of the patients are diagnosed at stage I (AJCC cancer staging) with 5-year survival rates of 100%, 5% of patients are diagnosed at stage IV with 5-year survival rates of approximately 26% .\n\nThe small percentage of women diagnosed at advanced stage of the disease gives evidence that mammography represents the best available screening option for breast cancer .\n\nHowever, more accurate and meaningful early-diagnosis methods together with image techniques would improve BC survival rates.\n\nMicroRNAs (MiRNAs) are short endogenous noncoding RNA molecules of 19-25 nt that have important gene regulatory roles at post-transcriptional level \\[8, 9\\]. They pair with messenger RNAs (mRNAs) of protein-coding genes and depending on complementarity, leading to mRNa translational repression or degradation . They regulate 30% of transcripts and contain 3% of the human genome .\n\nIn the past few years, miRNAs were established as relevant molecular components of cells in normal or malignant processes.. Particularly, miRNAs have been demonstrated to have an important role in cancer biology through post transcriptional editing of target messenger RNAs expression involved in tumor growth, invasion, metastasis or immune escape .\n\nIn addition, several tumor-associated miRNA profiles have been proposed and investigated as biomarkers for diagnosis, survival, response to treatment or tumor subclassification.\n\nThe development of early diagnostic tools is of most interest to the clinics since early diagnosis is associated with better prognosis.\n\nIn this context, miRNAs have been demonstrated to be good early diagnostic biomarkers in several types of cancer including BC, among others.\n\nOne of the main advantages of circulating miRNAs is their high stability in body fluids , which is the main reason for them to be used in cancer diagnosis or prognosis.\n\nMoreover, the assessment of circulating miRNAs can be carried out with simple, lowcost and quick assays.\n\nThese characteristics highlight the value of miRNAs as non-invasive biomarkers. Indeed, several miRNAs have been found to be differentially expressed in blood, plasma or serum from healthy donors compared with BC patients, supporting their use as noninvasive, early-stage diagnosis biomarkers.\n\nGrowing evidences revealed that imaging techniques are associated with some limitations such as expensive. Hence, it seems that utilization of improvement imaging techniques and biochemistry biomarkers could overcome the limitations associated with imaging techniques. Beside utilization of imaging techniques, identification of new biomarkers in patients with breast cancer has provided an interesting landscape .\n\nSo studies have identified different circulating miRNAs as new biomarkers for BC detection; Moreover, they have not been assessed in conjunction with diagnostic imaging, which is used for quantifying the extent of the disease and provides information related to tumour aggressiveness representing an obligatory step for treatment planning. The use of diagnostic imaging to extract quantitative parameters related to the morphology, metabolism and functionality of tumours, as well as to correlate specific imaging parameters with molecular biomarkers, is an emerging research topic"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'females 18 years old or above', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. control group of normal healthy individuals who don't have tumors in other organs.\n2. breast cancer group Patients with confirmed breast cancer who didn't receive radiotherapy ,chemotherapy ,hormonal therapy or surgical treatment.\n\nExclusion Criteria:\n\n1. Patients refuse to be part of study and undergo examination .\n2. All patients with breast cancer that had received chemotherapy, radiotherapy , ,hormonal or surgical treatment.\n3. History of benign or malignant tumors in other organs"}, 'identificationModule': {'nctId': 'NCT04778202', 'briefTitle': 'Diagnostic and Prognostic Value of MicroRNA in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic and Prognostic Value of MicroRNA as a Potential Biomarker in Breast Cancer Patients in Correlation to Radiological Findings.', 'orgStudyIdInfo': {'id': 'MicroRNA in breast cancer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'first group (control group)', 'description': '25 normal health control women apparently healthy. blood samples will be obtained after getting informed consent', 'interventionNames': ['Diagnostic Test: blood sample collection']}, {'label': 'Second group (breast cancer patient group)', 'description': '25 female patients referred to radiology departement at South Egypt Cancer Institute or Assiut University Hospital diagnosed as breast cancer patients as evidenced by clinical examination , mammography and histopathology', 'interventionNames': ['Diagnostic Test: blood sample collection']}], 'interventions': [{'name': 'blood sample collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood sample collection by venipuncture four both groups and MRI for breast cancr patient group', 'armGroupLabels': ['Second group (breast cancer patient group)', 'first group (control group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Asmaa Abdelghfour', 'role': 'CONTACT', 'email': 'asmaasalh104@gmail.com', 'phone': '01114081316'}, {'name': 'Tahia Hashim Saleem', 'role': 'CONTACT', 'email': 'tahia.saleem@yahoo.com', 'phone': '01060560791'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'demonstrator', 'investigatorFullName': 'asmaa saleh abdelghfour', 'investigatorAffiliation': 'Assiut University'}}}}