Kidney CancerNCT06531629
Risk-based Screen and Prognostic Analysis for Second Primary Malignancies in Kidney Cancer Patients
An observational study of Kidney Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
Second primary malignancy (SPM) significantly impacts the survival and prognosis of patients. This study endeavors to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct predictive nomograms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Surgery, radiation therapy and chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 72,408 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospectively reviewing data were obtained from the Surveillance, Epidemiology, and End Results (SEER) database (https://seer.cancer.gov/) from 2000-2020 using SEER Stat 8.4.1. 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 kidney cancer patients were identified from the SEER database.
Who may be able to join
- (1) Diagnosed age was between 18 and 80 years old
- (2) Diagnosed histologically confirmed as first primary kidney cancer
- (3) The staging of kidney cancer was early or localized advanced (T1/2/3N0M0)
- (4) Detailed survival data and follow-up information should be provided
Who cannot join
- (1) Histological conformation for diagnosis was unavailable
- (2) The type of reporting source was "Death certificate only" or "Autopsy only"
- (3) Patients with other malignancies before the diagnosis of primary kidney cancer
- (4) The staging of kidney cancer was not early or localized advanced (T1/2/3N0M0)
- (5) Diagnosis interval between first primary malignancy (FPM) and second primary malignancy (SPM) was less than 6 months
- (6) The information was not complete
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Risk-based Screen and Prognostic Analysis for Second Primary Malignancies in Kidney Cancer Patients: A Retrospective Cohort Study Based on Large-scale Population and Mendelian Randomization Analysis
Second primary malignancy (SPM) significantly impacts the survival and prognosis of patients. This study endeavors to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct predictive nomograms.
Read the detailed description
In recent years, with the advancement of cancer treatment techniques and the prolonged survival of patients, the prevalence of Second primary malignancy (SPM) has been escalating, emerging as a significant health issue among cancer survivors. The goal of this study is to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct nomograms to provide clinical evidence. The main questions this study aims to answer are: (1) What are the risk factors associated with the prevalence of SPM after kidney cancer? (2) What are the prognostic factors associated with the overall survival (OS) of kidney cancer patients with SPM? (3) How to accurately predict the probability of developing SPM after kidney cancer and the OS of kidney cancer patients with SPM? In this retrospective population-based cohort study, Patients diagnosed with first primary kidney cancer between 2000 and 2020 were retrospectively enrolled from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will concentrate on the risk and prognostic factors of SPM after kidney cancer, and develop nomograms to forecast the development and overall survival (OS) of SPM after kidney cancer.
- Conditions
- Kidney Cancer
- Being tested
- Surgery, radiation therapy and chemotherapy
- Keywords
- Kidney cancer, Prediction model, Prognosis, Risk factors, Second primary malignancy
- Medical subject headings
- Kidney Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery, radiation therapy and chemotherapyProcedure or surgery
Surgery, radiation therapy and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Kidney cancer patients with second primary malignancy (SPM) | Patients diagnosed with first primary kidney cancer and second primary malignancy between 2000 and 2020 Receives: Procedure: Surgery, radiation therapy and chemotherapy | |
| Kidney cancer patients without SPM | Patients diagnosed with only first primary kidney cancer between 2000 and 2020 Receives: Procedure: Surgery, radiation therapy and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a second primary malignancy (SPM)
This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy.
Measured: This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy, assessed up to 20 years.
Overall survival (OS)
OS was calculated as the time interval from the diagnosis of the second primary malignancy to death or the time to the last follow-up.
Measured: From the date of diagnosis of the second primary malignancy to the date of death from any cause or the data 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 malignancy to death from the same disease or the last follow-up.
Measured: From date of diagnosis of the second primary malignancy 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 posted1 Aug 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.
- Other trials for Kidney 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
- Retrospective
- Enrolment
- 72,408 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
- NCT06531629
- Sponsor's protocol ID
- 2024#07-03
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-based Screen and Prognostic Analysis for Second Primary Malignancies in Kidney Cancer Patients: A Retrospective Cohort Study Based on Large-scale Population and Mendelian Randomization Analysis
- ClinicalTrials.gov ID
- NCT06531629
- Acronym / sponsor ID
- 2024#07-03
- Conditions
- Kidney Cancer
- Keywords
- Kidney cancer, Prediction model, Prognosis, Risk factors, Second primary malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72,408 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
- 1 Aug 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.
Second primary malignancy (SPM) significantly impacts the survival and prognosis of patients. This study endeavors to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct predictive nomograms.
Detailed description
In recent years, with the advancement of cancer treatment techniques and the prolonged survival of patients, the prevalence of Second primary malignancy (SPM) has been escalating, emerging as a significant health issue among cancer survivors. The goal of this study is to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct nomograms to provide clinical evidence. The main questions this study aims to answer are: (1) What are the risk factors associated with the prevalence of SPM after kidney cancer? (2) What are the prognostic factors associated with the overall survival (OS) of kidney cancer patients with SPM? (3) How to accurately predict the probability of developing SPM after kidney cancer and the OS of kidney cancer patients with SPM? In this retrospective population-based cohort study, Patients diagnosed with first primary kidney cancer between 2000 and 2020 were retrospectively enrolled from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will concentrate on the risk and prognostic factors of SPM after kidney cancer, and develop nomograms to forecast the development and overall survival (OS) of SPM after kidney cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney cancer patients with second primary malignancy (SPM) | – | Procedure: Surgery, radiation therapy and chemotherapyPatients diagnosed with first primary kidney cancer and second primary malignancy between 2000 and 2020 |
| Kidney cancer patients without SPM | – | Procedure: Surgery, radiation therapy and chemotherapyPatients diagnosed with only first primary kidney cancer between 2000 and 2020 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospectively reviewing data were obtained from the Surveillance, Epidemiology, and End Results (SEER) database (https://seer.cancer.gov/) from 2000-2020 using SEER Stat 8.4.1. 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 kidney cancer patients were identified from the SEER database.
Key inclusion criteria (4 listed)
- (1) Diagnosed age was between 18 and 80 years old
- (2) Diagnosed histologically confirmed as first primary kidney cancer
- (3) The staging of kidney cancer was early or localized advanced (T1/2/3N0M0)
- (4) Detailed survival data and follow-up information should be provided
Key exclusion criteria (6 listed)
- (1) Histological conformation for diagnosis was unavailable
- (2) The type of reporting source was "Death certificate only" or "Autopsy only"
- (3) Patients with other malignancies before the diagnosis of primary kidney cancer
- (4) The staging of kidney cancer was not early or localized advanced (T1/2/3N0M0)
- (5) Diagnosis interval between first primary malignancy (FPM) and second primary malignancy (SPM) was less than 6 months
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, radiation therapy and chemotherapySurgery, radiation therapy and chemotherapy | Procedure or surgery | Kidney cancer patients with second primary malignancy (SPM), Kidney cancer patients without SPM |
Primary outcome
Developing a second primary malignancy (SPM)
Time frame: This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy, assessed up to 20 years.
This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy.
Overall survival (OS)
Time frame: From the date of diagnosis of the second primary malignancy to the date of death from any cause or the data 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 malignancy 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 malignancy 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 6 Aug 2024.
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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 6 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 6 Aug 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?
Developing a second primary malignancy (SPM) (time frame: This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy, assessed up to 20 years.). The study lists 2 primary outcomes in all. 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 6 Aug 2024.