Renal Cell Carcinoma (RCC)NCT07117786
Computed Tomography Radiomics-Derived Nomogram for Predicting Early Renal Function Decline After Partial Nephrectomy in Renal Cell Carcinoma: A Multicenter Development/Validation Study
An observational study of Renal Cell Carcinoma (RCC), run by First Affiliated Hospital of Fujian Medical University.
Trial summary
The goal of this observational study is to explore the relationship between CT-based radiomics and postoperative renal function changes in patients with localized renal cell carcinoma (RCC) undergoing partial nephrectomy (PN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- CT Contrast and Computed Tomography
- How many people
- 1,437 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jun 2023
- 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: The study population was drawn from the following institutions: the First Affiliated Hospital of Fujian Medical University, the Second Affiliated Hospital of Fujian Medical University, the First Affiliated Hospital of Xiamen University, the Second People's Hospital affiliated with Fujian University of Traditional Chinese Medicine, the First Affiliated Hospital of Chongqing Medical University, and Quanzhou First Hospital affiliated with Fujian Medical University
Who may be able to join
- (1) postoperative pathological confirmation of RCC; (2) preoperative contrast-enhanced CT of the kidney or abdomen.
Who cannot join
- (1) absence of corticomedullary, nephrographic, or excretory phase CT sequences; (2) poor-quality CT images unsuitable for analysis; (3) incomplete clinicopathologic data; (4) missing renal function data during postoperative follow-up; (5) unavailable renal function assessment within two weeks before surgery.
About this study
The goal of this observational study is to explore the relationship between CT-based radiomics and postoperative renal function changes in patients with localized renal cell carcinoma (RCC) undergoing partial nephrectomy (PN). The main question it aims to answer is: Can a radiomics-clinical nomogram integrating CT-based radiomics features with preoperative and intraoperative clinical variables accurately predict early postoperative renal function decline in patients with localized RCC undergoing PN? Participants already undergoing renal CT examination and scheduled for postoperative renal function testing as part of the routine perioperative care will receive renal function assessment after completing surgical treatment for RCC.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- CT Contrast, Computed Tomography
- Keywords
- Renal Function Decline, Renal Cell Carcinoma, Computed Tomography
- 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.
CT ContrastOther
Participants will undergo a CT-based radiomics assessment as part of the intervention. This approach involves the extraction of high-dimensional quantitative imaging features from preoperative contrast-enhanced CT scans, which are then analyzed using machine learning algorithms to identify patterns predictive of early postoperative renal function decline. Unlike conventional radiologic evaluations that rely on visual inspection and basic metrics (e.g., tumor size or enhancement), this radiomics-based intervention captures subtle heterogeneity within renal tumors and surrounding parenchyma. The integration of these features with clinical variables distinguishes this study from other imaging or predictive model studies, enabling the development of a personalized nomogram for patients with localized RCC undergoing partial nephrectomy.
Computed TomographyOther
Participants will undergo a CT-based radiomics assessment as part of the intervention. This approach involves the extraction of high-dimensional quantitative imaging features from preoperative contrast-enhanced CT scans, which are then analyzed using machine learning algorithms to identify patterns predictive of early postoperative renal function decline. Unlike conventional radiologic evaluations that rely on visual inspection and basic metrics (e.g., tumor size or enhancement), this radiomics-based intervention captures subtle heterogeneity within renal tumors and surrounding parenchyma. The integration of these features with clinical variables distinguishes this study from other imaging or predictive model studies, enabling the development of a personalized nomogram for patients with localized RCC undergoing partial nephrectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative renal function decline
early Renal function decline after PN was defined as a ≥25% reduction in eGFR from the preoperative baseline within 3 to 24 months postoperatively
Measured: within 3 to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jan 2016
- Primary completion6 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies 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
- 1,437 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117786
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU [2025]570
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Radiomics-Derived Nomogram for Predicting Early Renal Function Decline After Partial Nephrectomy in Renal Cell Carcinoma: A Multicenter Development/Validation Study
- ClinicalTrials.gov ID
- NCT07117786
- Acronym / sponsor ID
- MRCTA, ECFAH of FMU [2025]570
- Conditions
- Renal Cell Carcinoma (RCC)
- Keywords
- Renal Function Decline, Renal Cell Carcinoma, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,437 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 12 Aug 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.
The goal of this observational study is to explore the relationship between CT-based radiomics and postoperative renal function changes in patients with localized renal cell carcinoma (RCC) undergoing partial nephrectomy (PN). The main question it aims to answer is: Can a radiomics-clinical nomogram integrating CT-based radiomics features with preoperative and intraoperative clinical variables accurately predict early postoperative renal function decline in patients with localized RCC undergoing PN? Participants already undergoing renal CT examination and scheduled for postoperative renal function testing as part of the routine perioperative care will receive renal function assessment after completing surgical treatment for RCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was drawn from the following institutions: the First Affiliated Hospital of Fujian Medical University, the Second Affiliated Hospital of Fujian Medical University, the First Affiliated Hospital of Xiamen University, the Second People's Hospital affiliated with Fujian University of Traditional Chinese Medicine, the First Affiliated Hospital of Chongqing Medical University, and Quanzhou First Hospital affiliated with Fujian Medical University
Key inclusion criteria (1 listed)
- (1) postoperative pathological confirmation of RCC; (2) preoperative contrast-enhanced CT of the kidney or abdomen.
Key exclusion criteria (1 listed)
- (1) absence of corticomedullary, nephrographic, or excretory phase CT sequences; (2) poor-quality CT images unsuitable for analysis; (3) incomplete clinicopathologic data; (4) missing renal function data during postoperative follow-up; (5) unavailable renal function assessment within two weeks before surgery.
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 |
|---|---|---|
| CT ContrastParticipants will undergo a CT-based radiomics assessment as part of the intervention. This approach involves the extraction of high-dimensional quantitative imaging features from preoperative contrast-enhanced CT scans, which are then analyzed using machine learning algorithms to identify patterns predictive of early postoperative renal function decline. Unlike conventional radiologic evaluations that rely on visual inspection and basic metrics (e.g., tumor size or enhancement), this radiomics-based intervention captures subtle heterogeneity within renal tumors and surrounding parenchyma. The integration of these features with clinical variables distinguishes this study from other imaging or predictive model studies, enabling the development of a personalized nomogram for patients with localized RCC undergoing partial nephrectomy. | Other | – |
| Computed TomographyParticipants will undergo a CT-based radiomics assessment as part of the intervention. This approach involves the extraction of high-dimensional quantitative imaging features from preoperative contrast-enhanced CT scans, which are then analyzed using machine learning algorithms to identify patterns predictive of early postoperative renal function decline. Unlike conventional radiologic evaluations that rely on visual inspection and basic metrics (e.g., tumor size or enhancement), this radiomics-based intervention captures subtle heterogeneity within renal tumors and surrounding parenchyma. The integration of these features with clinical variables distinguishes this study from other imaging or predictive model studies, enabling the development of a personalized nomogram for patients with localized RCC undergoing partial nephrectomy. | Other | – |
Primary outcome
early postoperative renal function decline
Time frame: within 3 to 24 months postoperatively
early Renal function decline after PN was defined as a ≥25% reduction in eGFR from the preoperative baseline within 3 to 24 months postoperatively
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 12 Aug 2025.
- 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. 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 Renal Cell Carcinoma (RCC), run by First Affiliated Hospital of Fujian Medical University.
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 1 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: finished, as of the sponsor's last update on 12 Aug 2025. 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?
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?
early postoperative renal function decline (time frame: within 3 to 24 months postoperatively). 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 12 Aug 2025.