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RecruitingNCT06147349Updated Nov 27, 2023

Kidney Cancer Observational Protocol

An observational study in Renal Cancer, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Jan 2010; still recruiting 16 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

A databasa was created with the intention of collecting data related to patients who underwent radical or partial nefrectomy surgery in an electronic case report form.

Each patient will be followed for 10 years approximately starting from the date of surgery for a total of 2 yearly visits for the first 5 years which could then be diluted in 1 visit per year for the remaining 5 years. At each visit control exams forseen by the standard care for post surgery patients will be evalued and tha data will then be transferred into the database. Yearly, a follow up questionnaire will be sent to the patients' home in order to obtain the information relative to possible relapses. The data collected will be handled following the most strict GCPs and privacy norms. The main objectives of the study are the collection and interpretation of the scientific data with the scope of: obtaining health benefits for the patients involved and for future patients with the same type of cancer, improving the scientific knowledge on the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of renal neoplasia.

02

Conditions studied

  • Renal Cancer

Keywords

  • Renal cancer
  • Radical Nephrectomy
  • Partial Nephrectomy
  • Relapse
  • Renal cancer diagnosis
  • Renal cancer treatment
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 218 across 216 observational studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with kidney cancer who underwent radical or partial nephrectomy

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
  • Absence of kidney cancer
  • Inability to read and sign the informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Experimental

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

    Procedure: Radical or partial nephrectomy

Interventions

  • ProcedureRadical or partial nephrectomy

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

06

What researchers measure

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.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • IRCCS Ospedale San Raffaele
    Milan, MI 20132, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06147349
Lead sponsor
IRCCS San Raffaele
Responsible party
Francesco Montorsi (Professor, IRCCS San Raffaele) — Principal investigator
First posted
Nov 27, 2023
Start date
Jan 27, 2010
Primary completion
Feb 4, 2028 (estimated)
Completion
Feb 4, 2028 (estimated)
Last update
Nov 27, 2023

Study contacts

Francesco Montorsi, MD.
Contact
montorsi.francesco@hsr.it
02 2643 7286
Francesco Fiorio, MSC
Contact
fiorio.francesco@hsr.it
02 2643 6268
Francesco Montorsi, MD
principal investigator · IRCCS Ospedale San Raffaele

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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