Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT03692533
Status:
UNKNOWN
Last Update Posted:
2018-10-02
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups : Group A include cases and Group B includes controls'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-29', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-29', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that develops recurrence of tumor as assessed by Multi slice CT', 'timeFrame': '2 years', 'description': 'Number of patients that develops recurrent tumor after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed'}, {'measure': 'Number of participants that develops Tumor metastasis as assessed by Multi slice CT', 'timeFrame': '2 years', 'description': 'Number of patients that develops tumor metastasis after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geminin, prognosis'], 'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '26406148', 'type': 'BACKGROUND', 'citation': 'Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.'}, {'pmid': '28055103', 'type': 'RESULT', 'citation': 'Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.'}, {'pmid': '26996659', 'type': 'RESULT', 'citation': 'Humphrey PA, Moch H, Cubilla AL, Ulbright TM, Reuter VE. The 2016 WHO Classification of Tumours of the Urinary System and Male Genital Organs-Part B: Prostate and Bladder Tumours. Eur Urol. 2016 Jul;70(1):106-119. doi: 10.1016/j.eururo.2016.02.028. Epub 2016 Mar 17.'}, {'pmid': '20633979', 'type': 'RESULT', 'citation': 'Ljungberg B, Cowan NC, Hanbury DC, Hora M, Kuczyk MA, Merseburger AS, Patard JJ, Mulders PF, Sinescu IC; European Association of Urology Guideline Group. EAU guidelines on renal cell carcinoma: the 2010 update. Eur Urol. 2010 Sep;58(3):398-406. doi: 10.1016/j.eururo.2010.06.032. Epub 2010 Jul 12.'}, {'pmid': '21741163', 'type': 'RESULT', 'citation': 'Sun M, Shariat SF, Cheng C, Ficarra V, Murai M, Oudard S, Pantuck AJ, Zigeuner R, Karakiewicz PI. Prognostic factors and predictive models in renal cell carcinoma: a contemporary review. Eur Urol. 2011 Oct;60(4):644-61. doi: 10.1016/j.eururo.2011.06.041. Epub 2011 Jun 30.'}, {'pmid': '14532767', 'type': 'RESULT', 'citation': 'Kim HL, Belldegrun AS, Freitas DG, Bui MH, Han KR, Dorey FJ, Figlin RA. Paraneoplastic signs and symptoms of renal cell carcinoma: implications for prognosis. J Urol. 2003 Nov;170(5):1742-6. doi: 10.1097/01.ju.0000092764.81308.6a.'}, {'pmid': '26969090', 'type': 'RESULT', 'citation': 'Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, Jewett M, Dutcher JP, Atkins MB, Pins M, Wilding G, Cella D, Wagner L, Matin S, Kuzel TM, Sexton WJ, Wong YN, Choueiri TK, Pili R, Puzanov I, Kohli M, Stadler W, Carducci M, Coomes R, DiPaola RS. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2016 May 14;387(10032):2008-16. doi: 10.1016/S0140-6736(16)00559-6. Epub 2016 Mar 9.'}, {'pmid': '15076282', 'type': 'RESULT', 'citation': 'Kim HL, Han KR, Zisman A, Figlin RA, Belldegrun AS. Cachexia-like symptoms predict a worse prognosis in localized t1 renal cell carcinoma. J Urol. 2004 May;171(5):1810-3. doi: 10.1097/01.ju.0000121440.82581.d3.'}, {'pmid': '22918393', 'type': 'RESULT', 'citation': 'Sim SH, Messenger MP, Gregory WM, Wind TC, Vasudev NS, Cartledge J, Thompson D, Selby PJ, Banks RE. Prognostic utility of pre-operative circulating osteopontin, carbonic anhydrase IX and CRP in renal cell carcinoma. Br J Cancer. 2012 Sep 25;107(7):1131-7. doi: 10.1038/bjc.2012.360. Epub 2012 Aug 23.'}, {'pmid': '27279544', 'type': 'RESULT', 'citation': 'Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.'}, {'pmid': '25427043', 'type': 'RESULT', 'citation': 'Wilkerson ML, Lin F, Liu H, Cheng L. The application of immunohistochemical biomarkers in urologic surgical pathology. Arch Pathol Lab Med. 2014 Dec;138(12):1643-65. doi: 10.5858/arpa.2014-0078-RA.'}, {'pmid': '15814627', 'type': 'RESULT', 'citation': 'Dudderidge TJ, Stoeber K, Loddo M, Atkinson G, Fanshawe T, Griffiths DF, Williams GH. Mcm2, Geminin, and KI67 define proliferative state and are prognostic markers in renal cell carcinoma. Clin Cancer Res. 2005 Apr 1;11(7):2510-7. doi: 10.1158/1078-0432.CCR-04-1776.'}, {'pmid': '24485757', 'type': 'RESULT', 'citation': 'Alexiev BA, Drachenberg CB. Clear cell papillary renal cell carcinoma: Incidence, morphological features, immunohistochemical profile, and biologic behavior: A single institution study. Pathol Res Pract. 2014 Apr;210(4):234-41. doi: 10.1016/j.prp.2013.12.009. Epub 2014 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The study aim is to prospectively assess the prognostic significance of immunohistochemical markers Geminin and Mcm-2 in cases of renal cell carcinoma and to detect its clinicopathological correlation.', 'detailedDescription': 'Renal cell carcinoma (RCC) is one of the most common urological malignancies. Approximately 338,000 people are diagnosed with RCC worldwide each year, representing approximately 2-3 % of all cancers.\n\nRCC can be classified into non-epithelial and epithelial, according to cell origin. The four major types are of epithelial origin includes: clear cell renal carcinoma (ccRCC), papillary, chromophobe renal carcinoma (chRCC) and collecting duct carcinoma. The most common subtype of RCC is ccRCC which accounts for approximately 70-80% of all renal cell carcinomas.\n\nPrognostic factors for RCC can be classified into: anatomical, histological, clinical, and molecular factors. Anatomical factors include tumor size, venous invasion, renal capsular invasion, adrenal involvement, Lymph node and distant metastasis. Histological factors include tumour grade, RCC subtype, sarcomatoid features, microvascular invasion, tumour necrosis, and invasion of the collecting system. Clinical factors include performance status, local symptoms, cachexia, anaemia, platelet count, neutrophil/lymphocyte ratio, C-reactive protein (CRP) and serum albumin.\n\nAs regard the molecular factors, numerous markers such as carbonic anhydrase IX, vascular endothelial growth factor (VEGF), hypoxia-inducible factor (HIF), Ki67, PTEN (phosphatase and tensin homolog), osteopontin and other cell cycle and proliferative markers are being investigated.\n\nThe efficiency and accuracy of biomarkers studies using immunohistochemical and tissue microarray techniques are still variable and unclear in regards to prognostic significance in patients with renal tumors. Multiple biomarkers shown to be significant to assess diagnosis and prognosis in these patients and other were not significant.\n\nIn the RCC cell cycle, minichromosome maintenance 2 (Mcm2), Geminin define the proliferative state. Investigators are able to determine differential levels of expression of various markers in normal tissue compared with indolent and aggressive tumors. Among platforms used in determining the presence of biological markers in surgical pathology specimens, immunohistochemistry is perhaps the most commonly available tool in the routine diagnostic laboratory. Immunohistochemistry allows detection of antigens expressed on tumor cells, hence permitting characterization of the tumor.\n\nThis study was designed to assess the prognostic significance of Geminin and Mcm-2 in cases of renal cell carcinoma and to assess its clinicopathological correlation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patients who will undergo radical or partial nephrectomy for primary Renal cell carcinoma (Group A).\n* Adult patients who will undergo simple nephrectomy for benign causes (Group B).\n\nExclusion criteria:\n\n* Patients with secondary renal metastasis.\n* Patients with metastatic spread at time of presentation or operation.\n* Patients with renal urothelial carcinomas.\n* Children with renal tumors (less than 18 years).\n* Patients who are unfit for surgical treatment.\n* Patients who are refusing surgical treatment.'}, 'identificationModule': {'nctId': 'NCT03692533', 'briefTitle': 'Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Immunohistochemical Markers , Geminin and Mcm2 in Prognosis of Renal Cell Carcinoma, and Its Clinicopathological Correlation. A Prospective Controlled Study', 'orgStudyIdInfo': {'id': 'Geminin and Mcm-2 in RCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Group (A) \\[study cases\\] Adult patients who will undergo radical or partial nephrectomy.for primary renal cell carcinoma.', 'interventionNames': ['Diagnostic Test: Immunohistochemistry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Group (B) \\[control cases\\] Adult patients who will undergo simple nephrectomy for benign causes', 'interventionNames': ['Diagnostic Test: Immunohistochemistry']}], 'interventions': [{'name': 'Immunohistochemistry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Histopathological study and evaluation:\n\nFor each case, the tissue samples will be evaluated by the pathologist for detecting the histopathology and in cases of malignant renal spicemens the pathologist will also assess the histologic type, Fuhrman nuclear grade, cellular invasion of perinephric fat, and the extent of any vascular invasion seen by microscopy.\n\nImmunohistochemistry:\n\nImmunohistochemical staining will be performed by using the following antibodies: Geminin and Minichromosome maintenance-2 (MCM-2).\n\nEvaluation of the immunohistochemical staining will be performed by light microscopy. The interpretation of immuno-reactivity will be performed in a quantitative manner by analyzing the extent of the staining positivity of the tumor cells. Immuno-staining of greater than 10% of tumor cells is required for scoring as a positive case.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed A Allam, PhD', 'role': 'CONTACT', 'email': 'm.abdelghany746@gmail.com', 'phone': '+201021474046', 'phoneExt': 'Ass.lecturer'}, {'name': 'Abdelmonem A Elhaggagy, MD', 'role': 'CONTACT', 'email': 'a.elhaggagy@aun.edu.eg', 'phone': '+201223980551', 'phoneExt': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Abdelghany Allam', 'investigatorAffiliation': 'Assiut University'}}}}