NCT06147349

Brief Summary

The aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress90%
Jan 2010Feb 2028

Study Start

First participant enrolled

January 27, 2010

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2028

Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

18 years

First QC Date

October 10, 2023

Last Update Submit

November 23, 2023

Conditions

Renal Cancer

Keywords

Renal cancerRadical NephrectomyPartial NephrectomyRelapseRenal cancer diagnosisRenal cancer treatment

Outcome Measures

Primary Outcomes (1)

  • Clinical parameter collection

    Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases.

    10 years

Study Arms (1)

Experimental

Patients with kidney cancer who underwent radical or partial kidney removal surgery

Procedure: Radical or partial nephrectomy

Interventions

Radical or partial nephrectomyPROCEDURE

Removal of neoplastic mass either by full kidney excision or by targeted cancer removal

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with kidney cancer who underwent radical or partial nephrectomy

You may qualify if:

  • years or older
  • Kidney cancer diagnosis
  • Indication to cancer removal through surgery
  • Ability to read and sign the informed consent

You may not qualify if:

  • Age \< 18 years
  • Absence of kidney cancer
  • Inability to read and sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Kidney NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francesco Montorsi, MD

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Montorsi, MD.

CONTACT

02 2643 7286montorsi.francesco@hsr.it

Francesco Fiorio, MSC

CONTACT

02 2643 6268fiorio.francesco@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

November 27, 2023

Study Start

January 27, 2010

Primary Completion (Estimated)

February 4, 2028

Study Completion (Estimated)

February 4, 2028

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)