Kidney InjuryNCT05392725
Epidemiological Study on Malignancy Complicated With Renal Injury
An observational study of Kidney Injury, run by RenJi Hospital.
Trial summary
The epidemiological study of tumor complicated with kidney disease can clarify the prevalence and risk factors of renal injury when malignant tumor is diagnosed, and understand the impact of malignant tumor complicated with renal injury on survival time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Injury
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2024
- 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: Patients initially diagnosed with malignancy in Shanghai Renji Hospital from July 2017 to June 2021
Who may be able to join
- Malignancy confirmed by pathology.
- Between 18-80 years old, regardless of gender; Patients initially diagnosed with malignant tumors in our hospital from July 2017 to June 2021; Waiver of informed consent.
Who cannot join
- Patients with benign tumor diagnosed by pathology; The patient refused to participate; Patients judged by other researchers as unsuitable for inclusion in the study.
About this study
The epidemiological study of tumor complicated with kidney disease can clarify the prevalence and risk factors of renal injury when malignant tumor is diagnosed, and understand the impact of malignant tumor complicated with renal injury on survival time. This study will bring enlightenment to clinicians, discover high-risk factors in time, and try to avoid renal damage factors in diagnosis and treatment. Early diagnosis and early treatment can partially terminate the progress of renal injury, avoid the suspension of treatment due to renal reasons, and avoid the occurrence of end-stage renal failure (ESRD).
Read the detailed description
- To determine the prevalence of malignant tumor complicated with renal injury and analyze the related risk factors.
- To compare the survival time of malignant tumor with or without renal injury
- Conditions
- Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function group | Observe survival time | |
| Renal dysfunction group | Observe survival time |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
survival time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lulin Min, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392725
- Sponsor's protocol ID
- KY2021-253-B
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Malignancy Complicated With Renal Injury
- ClinicalTrials.gov ID
- NCT05392725
- Acronym / sponsor ID
- KY2021-253-B
- Conditions
- Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 May 2022 (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 epidemiological study of tumor complicated with kidney disease can clarify the prevalence and risk factors of renal injury when malignant tumor is diagnosed, and understand the impact of malignant tumor complicated with renal injury on survival time. This study will bring enlightenment to clinicians, discover high-risk factors in time, and try to avoid renal damage factors in diagnosis and treatment. Early diagnosis and early treatment can partially terminate the progress of renal injury, avoid the suspension of treatment due to renal reasons, and avoid the occurrence of end-stage renal failure (ESRD).
Detailed description
- To determine the prevalence of malignant tumor complicated with renal injury and analyze the related risk factors.
- To compare the survival time of malignant tumor with or without renal injury
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal renal function group | – | –Observe survival time |
| Renal dysfunction group | – | –Observe survival time |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients initially diagnosed with malignancy in Shanghai Renji Hospital from July 2017 to June 2021
Key inclusion criteria (2 listed)
- Malignancy confirmed by pathology.
- Between 18-80 years old, regardless of gender; Patients initially diagnosed with malignant tumors in our hospital from July 2017 to June 2021; Waiver of informed consent.
Key exclusion criteria (1 listed)
- Patients with benign tumor diagnosed by pathology; The patient refused to participate; Patients judged by other researchers as unsuitable for inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival
Time frame: 3 years
survival time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
Related trials for Kidney Injury
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Not yet recruiting
Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury
Acute Kidney Injury (AKI)
RecruitingPhase 2
Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
Kidney Injury, Acute
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, run by RenJi Hospital.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
survival (time frame: 3 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 26 May 2022.