Renal TumorsNCT06761742
Development of AI Model for Renal Tumor Diagnosis Using CT and Lab Tests
An observational study of Renal Tumors, run by RenJi Hospital at 1 site in China.
Trial summary
This multi-center retrospective study aims to develop a multimodal artificial intelligence diagnostic model using preoperative contrast-enhanced CT images and routine laboratory parameters from patients with renal tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Tumors
- How many people
- 1,922 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of patients who underwent renal tumor resection at multiple centers, with complete preoperative imaging and laboratory data. Eligible participants include those with pathological diagnoses of clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, renal angiomyolipoma, or renal oncocytoma. Patients with incomplete imaging data, poor-quality CT images, or coexistence of multiple pathological types of renal tumors were excluded.
Who may be able to join
- Underwent renal tumor resection with a complete postoperative pathological report, and the pathological diagnosis is one of the following types: clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, renal angiomyolipoma, or renal oncocytoma.
- Complete and available four-phase contrast-enhanced CT scans prior to surgery.
- Complete and available routine laboratory test results prior to surgery.
Who cannot join
- Incomplete CT data or poor image quality that affects diagnostic analysis.
- A time interval of more than three months between imaging or laboratory testing and pathological diagnosis.
- Patients diagnosed with fat-rich renal angiomyolipoma (AML).
- Pathological diagnosis indicating the coexistence of two or more pathological types of renal tumors.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200120
About this study
Official title: An Artificial Intelligence Model for Accurate Diagnosis of Renal Tumors Based on Multi-phase Contrast-enhanced CT and Laboratory Tests: A Model Development and Multi-center Evaluation Study
This multi-center retrospective study aims to develop a multimodal artificial intelligence diagnostic model using preoperative contrast-enhanced CT images and routine laboratory parameters from patients with renal tumors. The model is designed to assist clinicians in accurately predicting the pathological subtypes of renal tumors preoperatively, enabling detailed diagnoses and advancing precision medicine.
- Conditions
- Renal Tumors
- Medical subject headings
- Carcinoma, Renal Cell
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 |
|---|---|---|
| Training Set | Not described | |
| Validation Set | Not described | |
| Internal Test Set | Not described | |
| External Test Set | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pathological report
Measured: From the time of surgery to the release of the postoperative pathological report (typically within 2 weeks post-surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TumorsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,922 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Fudan University Pudong Medical Center, Fudan University, The Affiliated Hospital Of Southwest Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761742
- Sponsor's protocol ID
- DiagnosisModel_RenalTumor_AI
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to interested research partners upon reasonable request to Wei Zhai or Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; the prerequisite for this is a data transfer agreement, approved by the legal departments of the requesting researcher and by all legal departments of the institutions that provided data for the study, and an ethics clearance.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence Model for Accurate Diagnosis of Renal Tumors Based on Multi-phase Contrast-enhanced CT and Laboratory Tests: A Model Development and Multi-center Evaluation Study
- ClinicalTrials.gov ID
- NCT06761742
- Acronym / sponsor ID
- DiagnosisModel_RenalTumor_AI
- Conditions
- Renal Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,922 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Fudan University Pudong Medical Center, Fudan University, The Affiliated Hospital Of Southwest Medical University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 7 Jan 2025 (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.
This multi-center retrospective study aims to develop a multimodal artificial intelligence diagnostic model using preoperative contrast-enhanced CT images and routine laboratory parameters from patients with renal tumors. The model is designed to assist clinicians in accurately predicting the pathological subtypes of renal tumors preoperatively, enabling detailed diagnoses and advancing precision medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training Set | – | – |
| Validation Set | – | – |
| Internal Test Set | – | – |
| External Test Set | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients who underwent renal tumor resection at multiple centers, with complete preoperative imaging and laboratory data. Eligible participants include those with pathological diagnoses of clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, renal angiomyolipoma, or renal oncocytoma. Patients with incomplete imaging data, poor-quality CT images, or coexistence of multiple pathological types of renal tumors were excluded.
Key inclusion criteria (3 listed)
- Underwent renal tumor resection with a complete postoperative pathological report, and the pathological diagnosis is one of the following types: clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, renal angiomyolipoma, or renal oncocytoma.
- Complete and available four-phase contrast-enhanced CT scans prior to surgery.
- Complete and available routine laboratory test results prior to surgery.
Key exclusion criteria (4 listed)
- Incomplete CT data or poor image quality that affects diagnostic analysis.
- A time interval of more than three months between imaging or laboratory testing and pathological diagnosis.
- Patients diagnosed with fat-rich renal angiomyolipoma (AML).
- Pathological diagnosis indicating the coexistence of two or more pathological types of renal tumors.
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
postoperative pathological report
Time frame: From the time of surgery to the release of the postoperative pathological report (typically within 2 weeks post-surgery).
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 7 Jan 2025.
- Individual participant dataSharing planned: Yes. Data will be made available to interested research partners upon reasonable request to Wei Zhai or Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; the prerequisite for this is a data transfer agreement, approved by the legal departments of the requesting researcher and by all legal departments of the institutions that provided data for the study, and an ethics clearance.
Related trials for Renal Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
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 Tumors, run by RenJi 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 3 inclusion and 4 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 7 Jan 2025. 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?
postoperative pathological report (time frame: From the time of surgery to the release of the postoperative pathological report (typically within 2 weeks post-surgery).). 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 7 Jan 2025.