Renal Cell CarcinomaPN-ProMMNCT07697417
Multimodal Prediction of Postoperative Prognosis After Partial Nephrectomy for Endophytic Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma and Kidney Neoplasms, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This retrospective observational cohort study aims to develop and externally validate an imaging-clinical multimodal fusion model for predicting postoperative prognosis in patients with endophytic renal cell carcinoma undergoing partial nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Kidney Neoplasms, Endophytic Renal Tumor
- What is being tested?
- Imaging-clinical multimodal prognostic modeling
- How many people
- 406 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 will include adult patients with endophytic renal cell carcinoma who underwent partial nephrectomy at participating medical centers and had available preoperative imaging, clinical, pathological, perioperative, and postoperative follow-up data. Patients will be identified retrospectively from institutional databases and electronic medical records.
Who may be able to join
- Patients diagnosed with renal cell carcinoma. Patients with endophytic renal tumors based on preoperative imaging assessment. Patients who underwent partial nephrectomy. Available preoperative contrast-enhanced computed tomography images. Available clinical, pathological, perioperative, and postoperative follow-up data.
- Age 18 years or older at the time of surgery.
Who cannot join
- Patients who underwent radical nephrectomy as the primary surgical treatment. Patients with missing or poor-quality preoperative imaging data. Patients with incomplete key clinical, pathological, or follow-up information. Patients with hereditary renal cancer syndromes. Patients with bilateral renal tumors or solitary kidney. Patients who received neoadjuvant systemic therapy before partial nephrectomy.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Development and External Validation of an Imaging-Clinical Multimodal Fusion Model for Predicting Postoperative Prognosis After Partial Nephrectomy in Patients With Endophytic Renal Cell Carcinoma
This retrospective observational cohort study aims to develop and externally validate an imaging-clinical multimodal fusion model for predicting postoperative prognosis in patients with endophytic renal cell carcinoma undergoing partial nephrectomy. Preoperative computed tomography imaging features, three-dimensional reconstruction-derived tumor characteristics, radiomics features, and clinical variables will be integrated using machine learning and deep learning approaches. The primary objective is to evaluate whether the multimodal model improves prediction of postoperative prognostic outcomes compared with single-modality models based on clinical or imaging features alone.
Read the detailed description
Partial nephrectomy is a standard nephron-sparing treatment for localized renal cell carcinoma. However, postoperative functional and oncologic outcomes remain heterogeneous, especially in patients with endophytic renal tumors, in whom tumor complexity may increase surgical difficulty and affect postoperative recovery. Conventional clinical variables and anatomical scoring systems may not fully capture the multidimensional risk profile of these patients.
This study will retrospectively collect clinical, pathological, perioperative, and imaging data from patients with endophytic renal cell carcinoma who underwent partial nephrectomy. Preoperative multiphase computed tomography images will be used for radiomics feature extraction and deep learning-based image representation. Three-dimensional reconstruction-derived tumor features and conventional clinical variables will also be incorporated.
The study will develop and validate multimodal prediction models, including clinical models, radiomics models, deep learning imaging models, and imaging-clinical fusion models. Model performance will be assessed using discrimination, calibration, and clinical utility metrics, including the area under the receiver operating characteristic curve, calibration curves, decision curve analysis, and external validation across independent cohorts.
- Conditions
- Renal Cell Carcinoma, Kidney Neoplasms, Endophytic Renal Tumor, Postoperative Renal Function, Partial Nephrectomy Outcome
- Being tested
- Imaging-clinical multimodal prognostic modeling
- Keywords
- Partial nephrectomy, Endophytic renal cell carcinoma, Multimodal prediction model, Radiomics, Deep learning, Three-dimensional reconstruction, Postoperative prognosis, Renal function, Pentafecta, External validation
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging-clinical multimodal prognostic modelingOther
Preoperative CT imaging features, radiomics features, three-dimensional reconstruction-derived features, and clinical variables will be retrospectively analyzed to develop and validate a multimodal model for predicting postoperative prognosis after partial nephrectomy. No intervention will be assigned to participants.
| Study group | Role | What they receive |
|---|---|---|
| Development Cohort | Patients with endophytic renal cell carcinoma who underwent partial nephrectomy and were included for model development and internal validation. Receives: Other: Imaging-clinical multimodal prognostic modeling | |
| External Validation Cohort 1 | An independent cohort of patients with endophytic renal cell carcinoma who underwent partial nephrectomy and were used for external validation of the prediction model. Receives: Other: Imaging-clinical multimodal prognostic modeling | |
| External Validation Cohort 2 | An independent validation cohort used to evaluate the generalizability of the multimodal prognostic prediction model. Receives: Other: Imaging-clinical multimodal prognostic modeling | |
| External Validation Cohort 3 | An additional independent validation cohort used to assess model robustness across different patient populations or institutions. Receives: Other: Imaging-clinical multimodal prognostic modeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Pentafecta Achievement After Partial Nephrectomy
Modified pentafecta achievement will be defined as the simultaneous fulfillment of predefined postoperative outcome criteria, including negative surgical margin, absence of major postoperative complications, preservation of renal function, absence of significant perioperative adverse events, and absence of early tumor recurrence or other prespecified unfavorable outcomes. Patients who do not meet all criteria will be classified as modified pentafecta failure.
Measured: From the date of partial nephrectomy to the last available postoperative follow-up, up to 12 months after surgery.
Secondary outcomes (4)
Postoperative eGFR Decline Greater Than 20%
A clinically significant decline in renal function will be defined as a decrease in estimated glomerular filtration rate greater than 20% compared with the preoperative baseline value.
Measured: From baseline to 3-12 months after partial nephrectomy
Major Postoperative Complications
Major postoperative complications will be defined as Clavien-Dindo grade III or higher complications occurring within the predefined postoperative period.
Measured: Within 30 or 90 days after partial nephrectomy
Positive Surgical Margin
Positive surgical margin will be determined according to the postoperative pathological report.
Measured: At final pathological evaluation after partial nephrectomy
Area Under the Receiver Operating Characteristic Curve of the Multimodal Model
The discriminatory performance of the multimodal model for predicting modified pentafecta achievement after partial nephrectomy will be evaluated using the area under the receiver operating characteristic curve.
Measured: At completion of model development and external validation, using postoperative outcome data up to 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jan 2026
- Primary completion30 May 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697417
- Sponsor's protocol ID
- PN-ProMM-KY2025391
- Acronym
- PN-ProMM
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because of privacy, ethical, and institutional data-use restrictions. De-identified data may be made available from the corresponding investigator upon reasonable request and with appropriate institutional approval, where applicable.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and External Validation of an Imaging-Clinical Multimodal Fusion Model for Predicting Postoperative Prognosis After Partial Nephrectomy in Patients With Endophytic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07697417
- Acronym / sponsor ID
- PN-ProMM / PN-ProMM-KY2025391
- Conditions
- Renal Cell Carcinoma, Kidney Neoplasms, Endophytic Renal Tumor, Postoperative Renal Function, Partial Nephrectomy Outcome
- Keywords
- Partial nephrectomy, Endophytic renal cell carcinoma, Multimodal prediction model, Radiomics, Deep learning, Three-dimensional reconstruction, Postoperative prognosis, Renal function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Jul 2026 (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 retrospective observational cohort study aims to develop and externally validate an imaging-clinical multimodal fusion model for predicting postoperative prognosis in patients with endophytic renal cell carcinoma undergoing partial nephrectomy. Preoperative computed tomography imaging features, three-dimensional reconstruction-derived tumor characteristics, radiomics features, and clinical variables will be integrated using machine learning and deep learning approaches. The primary objective is to evaluate whether the multimodal model improves prediction of postoperative prognostic outcomes compared with single-modality models based on clinical or imaging features alone.
Detailed description
Partial nephrectomy is a standard nephron-sparing treatment for localized renal cell carcinoma. However, postoperative functional and oncologic outcomes remain heterogeneous, especially in patients with endophytic renal tumors, in whom tumor complexity may increase surgical difficulty and affect postoperative recovery. Conventional clinical variables and anatomical scoring systems may not fully capture the multidimensional risk profile of these patients.
This study will retrospectively collect clinical, pathological, perioperative, and imaging data from patients with endophytic renal cell carcinoma who underwent partial nephrectomy. Preoperative multiphase computed tomography images will be used for radiomics feature extraction and deep learning-based image representation. Three-dimensional reconstruction-derived tumor features and conventional clinical variables will also be incorporated.
The study will develop and validate multimodal prediction models, including clinical models, radiomics models, deep learning imaging models, and imaging-clinical fusion models. Model performance will be assessed using discrimination, calibration, and clinical utility metrics, including the area under the receiver operating characteristic curve, calibration curves, decision curve analysis, and external validation across independent cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Development Cohort | – | Other: Imaging-clinical multimodal prognostic modelingPatients with endophytic renal cell carcinoma who underwent partial nephrectomy and were included for model development and internal validation. |
| External Validation Cohort 1 | – | Other: Imaging-clinical multimodal prognostic modelingAn independent cohort of patients with endophytic renal cell carcinoma who underwent partial nephrectomy and were used for external validation of the prediction model. |
| External Validation Cohort 2 | – | Other: Imaging-clinical multimodal prognostic modelingAn independent validation cohort used to evaluate the generalizability of the multimodal prognostic prediction model. |
| External Validation Cohort 3 | – | Other: Imaging-clinical multimodal prognostic modelingAn additional independent validation cohort used to assess model robustness across different patient populations or institutions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients with endophytic renal cell carcinoma who underwent partial nephrectomy at participating medical centers and had available preoperative imaging, clinical, pathological, perioperative, and postoperative follow-up data. Patients will be identified retrospectively from institutional databases and electronic medical records.
Key inclusion criteria (2 listed)
- Patients diagnosed with renal cell carcinoma. Patients with endophytic renal tumors based on preoperative imaging assessment. Patients who underwent partial nephrectomy. Available preoperative contrast-enhanced computed tomography images. Available clinical, pathological, perioperative, and postoperative follow-up data.
- Age 18 years or older at the time of surgery.
Key exclusion criteria (1 listed)
- Patients who underwent radical nephrectomy as the primary surgical treatment. Patients with missing or poor-quality preoperative imaging data. Patients with incomplete key clinical, pathological, or follow-up information. Patients with hereditary renal cancer syndromes. Patients with bilateral renal tumors or solitary kidney. Patients who received neoadjuvant systemic therapy before partial nephrectomy.
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 |
|---|---|---|
| Imaging-clinical multimodal prognostic modelingPreoperative CT imaging features, radiomics features, three-dimensional reconstruction-derived features, and clinical variables will be retrospectively analyzed to develop and validate a multimodal model for predicting postoperative prognosis after partial nephrectomy. No intervention will be assigned to participants. | Other | Development Cohort, External Validation Cohort 1, External Validation Cohort 2, External Validation Cohort 3 |
Primary outcome
Modified Pentafecta Achievement After Partial Nephrectomy
Time frame: From the date of partial nephrectomy to the last available postoperative follow-up, up to 12 months after surgery.
Modified pentafecta achievement will be defined as the simultaneous fulfillment of predefined postoperative outcome criteria, including negative surgical margin, absence of major postoperative complications, preservation of renal function, absence of significant perioperative adverse events, and absence of early tumor recurrence or other prespecified unfavorable outcomes. Patients who do not meet all criteria will be classified as modified pentafecta failure.
4 secondary outcomes
Postoperative eGFR Decline Greater Than 20%
Time frame: From baseline to 3-12 months after partial nephrectomy
Major Postoperative Complications
Time frame: Within 30 or 90 days after partial nephrectomy
Positive Surgical Margin
Time frame: At final pathological evaluation after partial nephrectomy
Area Under the Receiver Operating Characteristic Curve of the Multimodal Model
Time frame: At completion of model development and external validation, using postoperative outcome data up to 12 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because of privacy, ethical, and institutional data-use restrictions. De-identified data may be made available from the corresponding investigator upon reasonable request and with appropriate institutional approval, where applicable.
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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.
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 Cell Carcinoma and Kidney Neoplasms, run by Tianjin Medical University Second 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 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Modified Pentafecta Achievement After Partial Nephrectomy (time frame: From the date of partial nephrectomy to the last available postoperative follow-up, up to 12 months after 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 13 Jul 2026.