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

NCT07697417 | Active Not Recruiting DMC

• 1 other identifier: PN-ProMM-KY2025391
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 1

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.

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; Pentafecta; External validation

Outcome Measures

Primary Outcomes (1)

• 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.

  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%

  From baseline to 3-12 months after partial nephrectomy

• Major Postoperative Complications

  Within 30 or 90 days after partial nephrectomy

• Positive Surgical Margin

  At final pathological evaluation after partial nephrectomy

• Area Under the Receiver Operating Characteristic Curve of the Multimodal Model

  At completion of model development and external validation, using postoperative outcome data up to 12 months after surgery.

Study Arms (4)

Development Cohort

Patients with endophytic renal cell carcinoma who underwent partial nephrectomy and were included for model development and internal validation.

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.

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.

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.

Other: Imaging-clinical multimodal prognostic modeling

Interventions

Imaging-clinical multimodal prognostic modeling OTHER

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.

Development Cohort; External Validation Cohort 1; External Validation Cohort 2; External Validation Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2026
• Primary Completion: May 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)