Development and Validation of a Prediction Model for AKI Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer

NCT06697613 | Completed

• 1 other identifier: SYSKY-2024-959-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian cancer is the most lethal malignant tumor of the female reproductive system. Cytoreduction surgery(CRS) combined with chemotherapy is the primary method for treating ovarian cancer, and complete tumor resection is an important means to improve prognosis. It has been demonstrated that the use of cisplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) following CRS can significantly improve the prognosis of some patients with ovarian cancer. However, HIPEC with cisplatin can lead to acute kidney injury (AKI), a serious complication that can seriously affect the patient's short- and long-term prognosis. NCCN guidelines recommend the use of sodium thiosulfate in all patients receiving HIPEC. This study intends to retrospectively collect clinical characteristics of patients to establish a prediction model for kidney injury, with a view to screening those at high risk of kidney injury for use of sodium thiosulfate for nephrotoxicity rescue in cisplatin HIPEC.

Conditions

Ovarian Cancer; AKI - Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Model prediction Probability

  Using the constructed clinical prediction model, the patient's baseline characteristics were input, and the model would output the probability of the patient developing AKI.

  Up to 7 days within CRS-HIPEC

• AUC (Area Under Curve)

  The AUC value of the model was calculated using the ROC (Receiver Operating Characteristic) Curve.

  Up to 7 days within CRS-HIPEC

Secondary Outcomes (1)

• The incidence of AKI.

  Up to 7 days within CRS-HIPEC

Study Arms (1)

CRS-HIPEC

Procedure: Hyperthermic intraperitoneal chemotherapy

Interventions

Hyperthermic intraperitoneal chemotherapy PROCEDURE

Patients diagnosed with FIGO Stage 3 or stage 4 ovarian cancer received hyperthermic intraperitoneal chemotherapy with cisplatin following cytoreductive surgery including primary debulking surgery, interval debulking surgery and secondary debulking surgery.

CRS-HIPEC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ovarian cancer were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with cisplatin.

You may qualify if:

• Patients who received HIPEC with cisplatin following cytoreductive surgery.
• Patients diagnosed with ovarian cancer pathologically.
• FIGO stage III-IV.

You may not qualify if:

• Use of renal protective drugs such as sodium perthiosulfate.
• Any grade of chronic or acute renal disease or other serious complications existed before HIPEC.
• Patients with single kidney.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (4)

• Colombo N, Sessa C, du Bois A, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent diseasedagger. Ann Oncol. 2019 May 1;30(5):672-705. doi: 10.1093/annonc/mdz062.

  PMID: 31046081 BACKGROUND

• Zivanovic O, Chi DS, Filippova O, Randall LM, Bristow RE, O'Cearbhaill RE. It's time to warm up to hyperthermic intraperitoneal chemotherapy for patients with ovarian cancer. Gynecol Oncol. 2018 Dec;151(3):555-561. doi: 10.1016/j.ygyno.2018.09.007. Epub 2018 Sep 22.

  PMID: 30249527 BACKGROUND

• Lemoine L, Sugarbaker P, Van der Speeten K. Drugs, doses, and durations of intraperitoneal chemotherapy: standardising HIPEC and EPIC for colorectal, appendiceal, gastric, ovarian peritoneal surface malignancies and peritoneal mesothelioma. Int J Hyperthermia. 2017 Aug;33(5):582-592. doi: 10.1080/02656736.2017.1291999.

  PMID: 28540826 BACKGROUND

• Hod T, Freedberg KJ, Motwani SS, Chen M, Frendl G, Leaf DE, Gupta S, Mothi SS, Richards WG, Bueno R, Waikar SS. Acute kidney injury after cytoreductive surgery and hyperthermic intraoperative cisplatin chemotherapy for malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2021 Apr;161(4):1510-1518. doi: 10.1016/j.jtcvs.2020.05.033. Epub 2020 May 29.

  PMID: 32631662 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Acute Kidney Injury

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2016
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)