Ovarian CancerNCT06697613
Development and Validation of a Prediction Model for AKI Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer
An observational study of Ovarian Cancer and AKI - Acute Kidney Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer, AKI - Acute Kidney Injury
- What is being tested?
- Hyperthermic intraperitoneal chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ovarian cancer were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with cisplatin.
Who may be able to join
- Patients who received HIPEC with cisplatin following cytoreductive surgery.
- Patients diagnosed with ovarian cancer pathologically.
- FIGO stage III-IV.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Development and Validation of a Prediction Model for Acute Kidney Injury Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer: a Multi-center Retrospective Cohort Study
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
- Being tested
- Hyperthermic intraperitoneal chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraperitoneal chemotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CRS-HIPEC | Not described Receives: Procedure: Hyperthermic intraperitoneal chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 7 days within CRS-HIPEC
Secondary outcomes (1)
The incidence of AKI.
The AKI would be diagnosed according to KDIGO 2012 criteria.
Measured: Up to 7 days within CRS-HIPEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jan 2016
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Principal investigator, Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697613
- Sponsor's protocol ID
- SYSKY-2024-959-01
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31046081Zivanovic 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.
PubMed 30249527Lemoine 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.
PubMed 28540826Hod 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.
PubMed 32631662
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prediction Model for Acute Kidney Injury Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer: a Multi-center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06697613
- Acronym / sponsor ID
- SYSKY-2024-959-01
- Conditions
- Ovarian Cancer, AKI - Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 20 Nov 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRS-HIPEC | – | Procedure: Hyperthermic intraperitoneal chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian cancer were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with cisplatin.
Key inclusion criteria (3 listed)
- Patients who received HIPEC with cisplatin following cytoreductive surgery.
- Patients diagnosed with ovarian cancer pathologically.
- FIGO stage III-IV.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Hyperthermic intraperitoneal chemotherapyPatients 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. | Procedure or surgery | CRS-HIPEC |
Primary outcome
Model prediction Probability
Time frame: Up to 7 days within CRS-HIPEC
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.
AUC (Area Under Curve)
Time frame: Up to 7 days within CRS-HIPEC
The AUC value of the model was calculated using the ROC (Receiver Operating Characteristic) Curve.
1 secondary outcome
The incidence of AKI.
Time frame: Up to 7 days within CRS-HIPEC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 31046081Colombo 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.
- Background: PubMed 30249527Zivanovic 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.
- Background: PubMed 28540826Lemoine 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.
- Background: PubMed 32631662Hod 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.
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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 Ovarian Cancer and AKI - Acute Kidney Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Model prediction Probability (time frame: Up to 7 days within CRS-HIPEC). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06697613, which also lists 4 linked publications.
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 20 Nov 2024.