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Multimodal Prediction of Postoperative Prognosis After Partial Nephrectomy for Endophytic Renal Cell Carcinoma

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07697417
Acronym
PN-ProMM
Enrollment
406
Registered
2026-07-13
Start date
2026-01-01
Completion date
2026-12-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endophytic Renal Tumor, Kidney Neoplasms, Partial Nephrectomy Outcome, Postoperative Renal Function, Renal Cell Carcinoma

Keywords

Partial nephrectomy, Endophytic renal cell carcinoma, Multimodal prediction model, Radiomics, Deep learning, Three-dimensional reconstruction, Postoperative prognosis, Renal function, Pentafecta, External validation

Brief 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. 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.

Interventions

OTHERImaging-clinical multimodal prognostic modeling

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.

Sponsors

Tianjin Medical University Second Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Modified Pentafecta Achievement After Partial NephrectomyFrom 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.

Secondary

MeasureTime frameDescription
Postoperative eGFR Decline Greater Than 20%From baseline to 3-12 months after partial nephrectomyA 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.
Major Postoperative ComplicationsWithin 30 or 90 days after partial nephrectomyMajor postoperative complications will be defined as Clavien-Dindo grade III or higher complications occurring within the predefined postoperative period.
Positive Surgical MarginAt final pathological evaluation after partial nephrectomyPositive surgical margin will be determined according to the postoperative pathological report.
Area Under the Receiver Operating Characteristic Curve of the Multimodal ModelAt completion of model development and external validation, using postoperative outcome data up to 12 months after surgery.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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026