Kidney CancerNCT06369519
Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma
An observational study of Kidney Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Surgery treatment or local tumor destruction.
- Type of treatment
- Surgery or procedure
- How many people
- 3,677 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2000to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: This study was based on the Surveillance, Epidemiology, and End Results (SEER) database, which contains the population-based data from 17 Registries covering approximately 26.5% of the U.S. population. The eligible sporadic localized BRCC patients were identified from the SEER database.
Who may be able to join
- Age ≥ 18 years.
- Clinical diagnosis of localized BRCC (M0) from 2000 to 2020.
- Active follow-up.
- Complete clinicopathological information.
Who cannot join
- Diagnosed by autopsy or death certificate only.
- Tending to suffer from hereditary RCC, including those complicating with pancreatic neuroendocrine tumor (pNET) or hemangioblastoma.
- Unavailable key information.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma: a Population-based Cohort Study
Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:
What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?
Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.
Read the detailed description
Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. This cohort study aims to identify prognostic factors, construct predictive nomograms, and optimize surgical treatment for sporadic BRCC patients. The main questions it aims to answer are:
What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients? In this retrospective population-based cohort study, patients diagnosed with sporadic BRCC between 2000 and 2020 were identified from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.
- Conditions
- Kidney Cancer
- Being tested
- Surgery treatment or local tumor destruction.
- Keywords
- Bilateral renal cell carcinoma, Surgery, Partial nephrectomy, Local tumor destruction, Nomogram
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery treatment or local tumor destruction.Procedure or surgery
Surgery treatments mainly include partial nephrectomy and radical nephrectomy. Local tumor destruction mainly includes renal mass ablation.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous BRCC patients | Synchronous BRCC is defined as the second primary RCC emerges within 6 months from the diagnosis of the first primary RCC. Receives: Procedure: Surgery treatment or local tumor destruction. | |
| Metachronous BRCC patients | Metachronous BRCC develops beyond 6 months from the diagnosis of the first primary RCC. Receives: Procedure: Surgery treatment or local tumor destruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was calculated as the time interval from the diagnosis of the second primary RCC to death or the time to the last follow-up.
Measured: From date of diagnosis of the second primary RCC until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 20 years.
Secondary outcomes (1)
Cancer-specific survival (CSS)
CSS was calculated as the time interval from the diagnosis of the second primary RCC to death from the same disease or the last follow-up.
Measured: From date of diagnosis of the second primary RCC until the date of death from the same disease or the date of last follow-up, whichever came first, assessed up to 20 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jan 2000
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 3,677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GONG Kan, Peking University First Hospital
- Investigators
- Kan Gong, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369519
- Sponsor's protocol ID
- 2023#17-23
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deng R, Qiu J, Shang J, Yu C, Tian P, Zhao Z, Cai L, Zhou J, Gong K. The long-term survival outcome of sporadic bilateral renal cell carcinoma and optimization of surgical treatment: a large-scale population-based cohort study. Clin Exp Med. 2024 Dec 21;25(1):20. doi: 10.1007/s10238-024-01535-5.
PubMed 39708253
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma: a Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT06369519
- Acronym / sponsor ID
- 2023#17-23
- Conditions
- Kidney Cancer
- Keywords
- Bilateral renal cell carcinoma, Surgery, Partial nephrectomy, Local tumor destruction, Nomogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,677 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Apr 2024 (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.
Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:
What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?
Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.
Detailed description
Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. This cohort study aims to identify prognostic factors, construct predictive nomograms, and optimize surgical treatment for sporadic BRCC patients. The main questions it aims to answer are:
What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients? In this retrospective population-based cohort study, patients diagnosed with sporadic BRCC between 2000 and 2020 were identified from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synchronous BRCC patients | – | Procedure: Surgery treatment or local tumor destruction.Synchronous BRCC is defined as the second primary RCC emerges within 6 months from the diagnosis of the first primary RCC. |
| Metachronous BRCC patients | – | Procedure: Surgery treatment or local tumor destruction.Metachronous BRCC develops beyond 6 months from the diagnosis of the first primary RCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was based on the Surveillance, Epidemiology, and End Results (SEER) database, which contains the population-based data from 17 Registries covering approximately 26.5% of the U.S. population. The eligible sporadic localized BRCC patients were identified from the SEER database.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Clinical diagnosis of localized BRCC (M0) from 2000 to 2020.
- Active follow-up.
- Complete clinicopathological information.
Key exclusion criteria (3 listed)
- Diagnosed by autopsy or death certificate only.
- Tending to suffer from hereditary RCC, including those complicating with pancreatic neuroendocrine tumor (pNET) or hemangioblastoma.
- Unavailable key information.
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 |
|---|---|---|
| Surgery treatment or local tumor destruction.Surgery treatments mainly include partial nephrectomy and radical nephrectomy. Local tumor destruction mainly includes renal mass ablation. | Procedure or surgery | Metachronous BRCC patients, Synchronous BRCC patients |
Primary outcome
Overall survival (OS)
Time frame: From date of diagnosis of the second primary RCC until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 20 years.
OS was calculated as the time interval from the diagnosis of the second primary RCC to death or the time to the last follow-up.
1 secondary outcome
Cancer-specific survival (CSS)
Time frame: From date of diagnosis of the second primary RCC until the date of death from the same disease or the date of last follow-up, whichever came first, assessed up to 20 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 39708253Deng R, Qiu J, Shang J, Yu C, Tian P, Zhao Z, Cai L, Zhou J, Gong K. The long-term survival outcome of sporadic bilateral renal cell carcinoma and optimization of surgical treatment: a large-scale population-based cohort study. Clin Exp Med. 2024 Dec 21;25(1):20. doi: 10.1007/s10238-024-01535-5.
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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. This study is not recruiting at the moment.
Kan Gong principal investigator
Peking University First Hospital
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 Kidney Cancer, run by Peking University First Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 17 Apr 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From date of diagnosis of the second primary RCC until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 20 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369519, which also lists 1 linked publication.
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 17 Apr 2024.