NCT03692533

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 20, 2018

Last Update Submit

September 29, 2018

Conditions

Renal Cell Carcinoma

Keywords

Geminin, prognosis

Outcome Measures

Primary Outcomes (2)

  • Number of participants that develops recurrence of tumor as assessed by Multi slice CT

    Number of patients that develops recurrent tumor after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

    2 years

  • Number of participants that develops Tumor metastasis as assessed by Multi slice CT

    Number of patients that develops tumor metastasis after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

    2 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group (A) \[study cases\] Adult patients who will undergo radical or partial nephrectomy.for primary renal cell carcinoma.

Diagnostic Test: Immunohistochemistry

Group B

ACTIVE COMPARATOR

Group (B) \[control cases\] Adult patients who will undergo simple nephrectomy for benign causes

Diagnostic Test: Immunohistochemistry

Interventions

ImmunohistochemistryDIAGNOSTIC_TEST

Histopathological study and evaluation: For 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. Immunohistochemistry: Immunohistochemical staining will be performed by using the following antibodies: Geminin and Minichromosome maintenance-2 (MCM-2). Evaluation 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.

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients who will undergo radical or partial nephrectomy for primary Renal cell carcinoma (Group A).
  • Adult patients who will undergo simple nephrectomy for benign causes (Group B).

You may not qualify if:

  • Patients with secondary renal metastasis.
  • Patients with metastatic spread at time of presentation or operation.
  • Patients with renal urothelial carcinomas.
  • Children with renal tumors (less than 18 years).
  • Patients who are unfit for surgical treatment.
  • Patients who are refusing surgical treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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: 26406148BACKGROUND

  • 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: 28055103RESULT

  • 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: 26996659RESULT

  • 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: 20633979RESULT

  • 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: 21741163RESULT

  • 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: 14532767RESULT

  • 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: 26969090RESULT

  • 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: 15076282RESULT

  • 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: 22918393RESULT

  • 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: 27279544RESULT

  • 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: 25427043RESULT

  • 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: 15814627RESULT

  • 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.

    PMID: 24485757RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Central Study Contacts

Mohamed A Allam, PhD

CONTACT

+201021474046m.abdelghany746@gmail.com

Abdelmonem A Elhaggagy, MD

CONTACT

+201223980551a.elhaggagy@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 2 groups : Group A include cases and Group B includes controls
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 2, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

October 2, 2018

Record last verified: 2018-09