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NCT Number: NCT06147349

Kidney Cancer Observational Protocol

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location status: Recruiting

Location contact

Francesco Fiorio, MSC

CONTACT

[email protected]

02 2643 6268

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Radical or partial nephrectomy

Procedure

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

Primary outcomes

  1. Clinical parameter collection

    Time frame: 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Fiorio, MSC

CONTACT

[email protected]

02 2643 6268

Francesco Montorsi, MD.

CONTACT

[email protected]

02 2643 7286

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

2007 - Rene: Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Radical Nefrectomy/Tumorectomy Surgery

Important dates

Study start
2010
Primary completion
2028
Study completion
2028
First posted
Nov 27, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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