Renal CancerNCT06147349
Kidney Cancer Observational Protocol
An observational study of Renal Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Radical or partial nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2010to 4 Feb 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with kidney cancer who underwent radical or partial nephrectomy
Who may be able to join
- 18 years or older
- Kidney cancer diagnosis
- Indication to cancer removal through surgery
- Ability to read and sign the informed consent
Who cannot join
- Age < 18 years
- Absence of kidney cancer
- Inability to read and sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Francesco Fiorio, MSC, 02 2643 6268, fiorio.francesco@hsr.it
About this study
Official 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
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.
- Conditions
- Renal Cancer
- Being tested
- Radical or partial nephrectomy
- Keywords
- Renal cancer, Radical Nephrectomy, Partial Nephrectomy, Relapse, Renal cancer diagnosis, Renal cancer treatment
- Medical subject headings
- Kidney Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical or partial nephrectomyProcedure or surgery
Removal of neoplastic mass either by full kidney excision or by targeted cancer removal
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients with kidney cancer who underwent radical or partial kidney removal surgery Receives: Procedure: Radical or partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start27 Jan 2010
- Primary completion4 Feb 2028 (estimated)
- Study completion4 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Montorsi, IRCCS San Raffaele
- Investigators
- Francesco Montorsi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147349
- Sponsor's protocol ID
- 2007 - Rene
- Status last verified
- Nov 2023
- First submitted
- 10 Oct 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06147349
- Acronym / sponsor ID
- 2007 - Rene
- Conditions
- Renal Cancer
- Keywords
- Renal cancer, Radical Nephrectomy, Partial Nephrectomy, Relapse, Renal cancer diagnosis, Renal cancer treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 27 Jan 2010 (actual)
- Primary completion
- 4 Feb 2028 (estimated)
- Study completion
- 4 Feb 2028 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Procedure: Radical or partial nephrectomyPatients with kidney cancer who underwent radical or partial kidney removal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with kidney cancer who underwent radical or partial nephrectomy
Key inclusion criteria (4 listed)
- 18 years or older
- Kidney cancer diagnosis
- Indication to cancer removal through surgery
- Ability to read and sign the informed consent
Key exclusion criteria (3 listed)
- Age < 18 years
- Absence of kidney cancer
- Inability to read and sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical or partial nephrectomyRemoval of neoplastic mass either by full kidney excision or by targeted cancer removal | Procedure or surgery | Experimental |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Montorsi, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Montorsi, MD. (02 2643 7286, montorsi.francesco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical parameter collection (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.