NCT04244136

Brief Summary

  1. 1.Calculation of the expected residual renal tissue volume using contrast CT in renal tumor patients and its effect on preoperative decision making
  2. 2.Calculating the modulation between the residual normal renal tissue volume measured 6 months post operatively and the preoperative estimated normal renal tissue volume.
  3. 3.Assessment of the value of adding residual normal renal tissue volume to the PADUA score in decision making.
  4. 4.To reach a suggested cut off value of residual renal tissue that is adequate for a NSS trial

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
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

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

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

January 24, 2020

Last Update Submit

October 7, 2020

Conditions

Renal Cell Carcinoma

Keywords

residual normal renal tissue

Outcome Measures

Primary Outcomes (1)

  • estimation of the efficacy of contrast CT IN Calculation of the expected residual normal renal tissue volume before renal tumor surgeries

    comparision between preopertive measured volume by CT and post operative measured volume by CT in NSS and by graded gar in radical nephrectomy after isolation of the normal renal tissue in extracted kidney

    3 years

Secondary Outcomes (1)

  • Assessment of the value of adding residual normal renal tissue volume to the PADUA score in decision making To reach a suggested cut off value of residual renal tissue that is adequate for a NSS trial

    4 years

Interventions

contrast CTDEVICE

contrast CT abdomen fir measurement of the volume of expected residual normal renal tissue before surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

renal tumor patients who are fit for renal tumor surgeries

You may qualify if:

  • All patients presented to oncology outpatient clinic in Assuit urology hospital diagnosed by contrast CT to have renal mass who are surgically fit for radical nephrectomy or NSS surgery.

You may not qualify if:

  • Patient who diagnosed to have stage T4 renal mass according to TNM staging. 2-CRI patients who cannot perform contrast study. 3-patients with tumors in non-functioning kidney 4-patients with secondary renal tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Long CJ, Canter DJ, Kutikov A, Li T, Simhan J, Smaldone M, Teper E, Viterbo R, Boorjian SA, Chen DY, Greenberg RE, Uzzo RG. Partial nephrectomy for renal masses >/= 7 cm: technical, oncological and functional outcomes. BJU Int. 2012 May;109(10):1450-6. doi: 10.1111/j.1464-410X.2011.10608.x. Epub 2012 Jan 5.

    PMID: 22221502BACKGROUND

  • Isotani S, Shimoyama H, Yokota I, Noma Y, Kitamura K, China T, Saito K, Hisasue S, Ide H, Muto S, Yamaguchi R, Ukimura O, Gill IS, Horie S. Novel prediction model of renal function after nephrectomy from automated renal volumetry with preoperative multidetector computed tomography (MDCT). Clin Exp Nephrol. 2015 Oct;19(5):974-81. doi: 10.1007/s10157-015-1082-6. Epub 2015 Jan 25.

    PMID: 25618493BACKGROUND

  • Zhang M, Zhao Z, Duan X, Deng T, Cai C, Wu W, Zeng G. Partial versus radical nephrectomy for T1b-2N0M0 renal tumors: A propensity score matching study based on the SEER database. PLoS One. 2018 Feb 28;13(2):e0193530. doi: 10.1371/journal.pone.0193530. eCollection 2018.

    PMID: 29489911BACKGROUND

  • Venkatramani V, Swain S, Satyanarayana R, Parekh DJ. Current Status of Nephron-Sparing Surgery (NSS) in the Management of Renal Tumours. Indian J Surg Oncol. 2017 Jun;8(2):150-155. doi: 10.1007/s13193-016-0587-0. Epub 2017 Jan 30.

    PMID: 28546710BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

Central Study Contacts

mohammed ragab, MD

CONTACT

01066237580mohammedurology14290@gmail.com

diaaelden abdelhamed, PHD

CONTACT

01001229936

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer in assiut urology hospital,assiut university,Egypt

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

December 1, 2020

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

October 8, 2020

Record last verified: 2020-10