Prospective Validation of Machine Learning Model to Predict Platinum Induced Nephrotoxicity in Cancer Patients

NCT07114276 | Completed

• 1 other identifier: TMU-JIRB N202211046
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the utility of predictive models for chemotherapy-induced nephrotoxicity in the Taiwanese cancer population. The investigators will prospectively collect clinical data from enrolled participants, including demographic information, comorbidities, laboratory data, and chemotherapy treatment details. After chemotherapy administration, participants' renal function will be monitored over time to assess the development of nephrotoxicity, based on changes in serum creatinine (SCr) and other relevant clinical criteria. The primary objective is to evaluate and compare the predictive performance of a machine learning model and clinical physicians, using the area under the receiver operating characteristic curve (AUROC) as the main metric for discrimination performance.

Conditions

Acute Kidney Disease; Chemotherapy Side Effects; Machine Learning; Acute Kidney Injury

Keywords

Acute kidney injury; Machine learning; Chemotherapy side effects; Acute kidney disease

Outcome Measures

Primary Outcomes (1)

• AUROC comparison

  Comparison of the area under the receiver-operator characteristic (ROC) curves between the predictions made by the machine learning models and by clinicians, to predict AKI within 14 days and AKD within 89 days

  89 days

Secondary Outcomes (1)

• Incidence and odd ratios in each risk level group

  89 days

Study Arms (1)

Patients received cisplatin or carboplatin

Standardized chemotherapy

Other: Machine learning models predictions of acute kidney injury and acute kidney disease

Interventions

Machine learning models predictions of acute kidney injury and acute kidney disease OTHER

Comparison of the performances of machine learning models and clinicians in predicting AKI within 14 days and AKD within 89 days

Patients received cisplatin or carboplatin

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to Wan Fang Hospital during the period of the study. Patients used at least one dose of cisplatin or carboplatin as chemotherapy.

You may qualify if:

• Patients under clinical diagnosis of cancer with treatments including at least taking one course treatment of Cisplatin and Carboplatin from Dec,2022 to July,2026, at least having one serum creatinine data before and after the administration, willing to provide DNA sample and sign the informed consent will be recruited.

You may not qualify if:

• Patients who are young than 20 years old or older than 89 years old, pregnant women, infected by Human Immunodeficiency Virus (HIV), administered by Ifosfamide, couldn't evaluate their kidney function, refuse to provide DNA sample and sign the informed consent will be excluded.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: collaborator
• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Wan Fang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hsiang-Yin Chen, Pharm.D.

  School of Pharmacy, Taipei Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 89 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: October 30, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)