Ovarian CancerNCT06533709
Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data
An observational study of Ovarian Cancer and Image, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This project intends to conduct a multicenter retrospective study to evaluate the satisfactory reduction of advanced ovarian cancer using PET-CT images, and explore the correlation between molecular biological characteristics and clinical characteristics of ovarian cancer through high-throughput sequencing genomics… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer, Image, Predation
- What is being tested?
- Radio-score
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 May 2026
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 96 patients with advanced ovarian cancer who underwent PET-CT examination before the surgery, and received primary debulking surgery at our center from July 2017 to April 2024 were included for model development. Additionally, 50 patients from Zhejiang Cancer Hospital were included for model validation.
Who may be able to join
- Pathological type is epithelial ovarian cancer.
- Underwent primary debulking surgery at our hospital.
- Postoperative pathological staging is FIGO stage IIB or above.
- Clinical, surgical, and pathological data of the patient are mostly complete.
Who cannot join
- Pathological type is non-epithelial ovarian cancer.
- Underwent fertility-preserving surgery or palliative surgery.
- Presence of infection during PET/CT image acquisition.
- Concurrent other malignant tumors.
- Severe diseases of other major organs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 520120
huaiwu Lu, 86+ 18688395806, luhuaiwu@mail.sysu.edu.cn
About this study
Official title: Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data and Its Clinical Application
This project intends to conduct a multicenter retrospective study to evaluate the satisfactory reduction of advanced ovarian cancer using PET-CT images, and explore the correlation between molecular biological characteristics and clinical characteristics of ovarian cancer through high-throughput sequencing genomics combined with radiomics.
Read the detailed description
Ovarian cancer is the gynecological malignant tumor with the highest fatality rate. More than 70% of patients are diagnosed with advanced stage, often involving various organs of the pelvis and abdomen, which increases the difficulty of surgical resection, and the 5-year survival rate is only 30%. Surgical treatment is the cornerstone of the treatment of ovarian cancer, and whether it can achieve satisfactory tumor reduction is an important factor affecting the prognosis of ovarian cancer. At present, the methods used to evaluate whether satisfactory tumor reduction can be achieved include Suidan score based on CT image and Fagotti score based on laparoscopic exploration, but there are problems such as low sensitivity, poor specificity or strong subjectivity, and the efficiency of predicting satisfactory tumor reduction is only about 60%. In recent years, PET-CT has been widely used in tumor diagnosis. Pet-ct combined with PET metabolic imaging technology and traditional CT scanning can help to distinguish the nature of tumors, assess the systemic tumor load, define the scope of the lesion, and provide the metabolic status of various parts of the body. The application value of PET-CT related imaging features and metabolic information in ovarian cancer needs to be clarified. Our team's previous study found that PET-CT related images and metabolic information showed certain advantages in predicting satisfactory resection of ovarian cancer, and the AUC reached 0.85, which was better than the current CT image score and laparoscopic score. Therefore, this project intends to conduct a multicenter retrospective study to evaluate the satisfactory tumor reduction rate of advanced ovarian cancer using PET-CT images to guide clinical practice and predict the prognosis of patients. At the same time, we will explore the molecular biological characteristics and clinical relevance of ovarian cancer through the combination of high-throughput sequencing genomics and radiomics.
- Conditions
- Ovarian Cancer, Image, Predation
- Being tested
- Radio-score
- Keywords
- Ovarian Cancer, PET-CT Image, Debulking Prediction Model
- Medical subject headings
- Ovarian Neoplasms, Predatory Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-scoreDiagnostic test
A score based on the LASSO regression model predicting the R0 resection of the primary debulking surgery of advanced ovarian cancer.
| Study group | Role | What they receive |
|---|---|---|
| SYSU cohort | Patients cohort from Sun Yat-sen Memorial Hospital, as the training cohort. Receives: Diagnostic Test: Radio-score | |
| ZJCH cohort | Patients cohort from Zhejiang Cancer Hospital, as the external validation cohort. Receives: Diagnostic Test: Radio-score |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection
In patients with advanced ovarian cancer, the residual status after initial cytoreductive surgery is defined as follows: complete resection is defined as R0 resection, whereas visible residual tumor lesions during surgery are defined as non-R0 resection
Measured: yes or not
Secondary outcomes (3)
5-year progression-free survival (PFS)
PFS was calculated from the date of the last chemotherapy until disease progression or death due to any cause.
Measured: 5 years
5-year overall survival (OS)
OS was calculated from the date of the primary debulking surgery until death due to any cause.
Measured: 5-year
Response to platinum-based chemotherapy
After the last chemotherapy, treatment efficacy was assessed according to NCCN guidelines. For primary tumor, patients who relapsed 6 months or more after initial chemotherapy were termed platinum-sensitive. In contrast, patients whose disease recurred in less than 6 months were classified as platinum-resistant.
Measured: At least 6 months after the last chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jun 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huaiwu Lu, Principal investigator, The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533709
- Sponsor's protocol ID
- SYSKY-2024-503-01
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248.
PubMed 11870167Feng Z, Wen H, Jiang Z, Liu S, Ju X, Chen X, Xia L, Xu J, Bi R, Wu X. A triage strategy in advanced ovarian cancer management based on multiple predictive models for R0 resection: a prospective cohort study. J Gynecol Oncol. 2018 Sep;29(5):e65. doi: 10.3802/jgo.2018.29.e65. Epub 2018 Apr 23.
PubMed 30022629Vergote I, Coens C, Nankivell M, Kristensen GB, Parmar MKB, Ehlen T, Jayson GC, Johnson N, Swart AM, Verheijen R, McCluggage WG, Perren T, Panici PB, Kenter G, Casado A, Mendiola C, Stuart G, Reed NS, Kehoe S; EORTC; MRC CHORUS study investigators. Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials. Lancet Oncol. 2018 Dec;19(12):1680-1687. doi: 10.1016/S1470-2045(18)30566-7. Epub 2018 Nov 6.
PubMed 30413383Suidan RS, Ramirez PT, Sarasohn DM, Teitcher JB, Iyer RB, Zhou Q, Iasonos A, Denesopolis J, Zivanovic O, Long Roche KC, Sonoda Y, Coleman RL, Abu-Rustum NR, Hricak H, Chi DS. A multicenter assessment of the ability of preoperative computed tomography scan and CA-125 to predict gross residual disease at primary debulking for advanced epithelial ovarian cancer. Gynecol Oncol. 2017 Apr;145(1):27-31. doi: 10.1016/j.ygyno.2017.02.020. Epub 2017 Feb 14.
PubMed 28209497Chereau E, Ballester M, Selle F, Cortez A, Darai E, Rouzier R. Comparison of peritoneal carcinomatosis scoring methods in predicting resectability and prognosis in advanced ovarian cancer. Am J Obstet Gynecol. 2010 Feb;202(2):178.e1-178.e10. doi: 10.1016/j.ajog.2009.10.856.
PubMed 20113693Wang J, Liu L, Pang H, Liu L, Jing X, Li Y. Preoperative PET/CT score can predict incomplete resection after debulking surgery for advanced serous ovarian cancer better than CT score, MTV, tumor markers and hematological markers. Acta Obstet Gynecol Scand. 2022 Nov;101(11):1315-1327. doi: 10.1111/aogs.14442. Epub 2022 Aug 18.
PubMed 35979992Palomar Munoz A, Cordero Garcia JM, Talavera Rubio MDP, Garcia Vicente AM, Pena Pardo FJ, Jimenez Londono GA, Soriano Castrejon A, Aranda Aguilar E. Value of [18F]FDG-PET/CT and CA125, serum levels and kinetic parameters, in early detection of ovarian cancer recurrence: Influence of histological subtypes and tumor stages. Medicine (Baltimore). 2018 Apr;97(17):e0098. doi: 10.1097/MD.0000000000010098.
PubMed 29702969Dondi F, Albano D, Bellini P, Camoni L, Treglia G, Bertagna F. Relationship between Baseline [18F]FDG PET/CT Semiquantitative Parameters and BRCA Mutational Status and Their Prognostic Role in Patients with Invasive Ductal Breast Carcinoma. Tomography. 2022 Oct 27;8(6):2662-2675. doi: 10.3390/tomography8060222.
PubMed 36412681Ye D, Lin S, Shao Z, Liu Y, Wu B, Huo C, Xu D, Pang SW, Huang C, Li J, Liu J, Wang L, Zhu T, Lu H. The optimal SVM model from multi-model comparison outperforms conventional criteria in preoperative prediction of ovarian cancer residual disease. J Ovarian Res. 2026 Jun 25. doi: 10.1186/s13048-026-02176-w. Online ahead of print.
PubMed 42351290
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data and Its Clinical Application
- ClinicalTrials.gov ID
- NCT06533709
- Acronym / sponsor ID
- SYSKY-2024-503-01
- Conditions
- Ovarian Cancer, Image, Predation
- Keywords
- Ovarian Cancer, PET-CT Image, Debulking Prediction Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Aug 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.
This project intends to conduct a multicenter retrospective study to evaluate the satisfactory reduction of advanced ovarian cancer using PET-CT images, and explore the correlation between molecular biological characteristics and clinical characteristics of ovarian cancer through high-throughput sequencing genomics combined with radiomics.
Detailed description
Ovarian cancer is the gynecological malignant tumor with the highest fatality rate. More than 70% of patients are diagnosed with advanced stage, often involving various organs of the pelvis and abdomen, which increases the difficulty of surgical resection, and the 5-year survival rate is only 30%. Surgical treatment is the cornerstone of the treatment of ovarian cancer, and whether it can achieve satisfactory tumor reduction is an important factor affecting the prognosis of ovarian cancer. At present, the methods used to evaluate whether satisfactory tumor reduction can be achieved include Suidan score based on CT image and Fagotti score based on laparoscopic exploration, but there are problems such as low sensitivity, poor specificity or strong subjectivity, and the efficiency of predicting satisfactory tumor reduction is only about 60%. In recent years, PET-CT has been widely used in tumor diagnosis. Pet-ct combined with PET metabolic imaging technology and traditional CT scanning can help to distinguish the nature of tumors, assess the systemic tumor load, define the scope of the lesion, and provide the metabolic status of various parts of the body. The application value of PET-CT related imaging features and metabolic information in ovarian cancer needs to be clarified. Our team's previous study found that PET-CT related images and metabolic information showed certain advantages in predicting satisfactory resection of ovarian cancer, and the AUC reached 0.85, which was better than the current CT image score and laparoscopic score. Therefore, this project intends to conduct a multicenter retrospective study to evaluate the satisfactory tumor reduction rate of advanced ovarian cancer using PET-CT images to guide clinical practice and predict the prognosis of patients. At the same time, we will explore the molecular biological characteristics and clinical relevance of ovarian cancer through the combination of high-throughput sequencing genomics and radiomics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYSU cohort | – | Diagnostic Test: Radio-scorePatients cohort from Sun Yat-sen Memorial Hospital, as the training cohort. |
| ZJCH cohort | – | Diagnostic Test: Radio-scorePatients cohort from Zhejiang Cancer Hospital, as the external validation cohort. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 96 patients with advanced ovarian cancer who underwent PET-CT examination before the surgery, and received primary debulking surgery at our center from July 2017 to April 2024 were included for model development. Additionally, 50 patients from Zhejiang Cancer Hospital were included for model validation.
Key inclusion criteria (4 listed)
- Pathological type is epithelial ovarian cancer.
- Underwent primary debulking surgery at our hospital.
- Postoperative pathological staging is FIGO stage IIB or above.
- Clinical, surgical, and pathological data of the patient are mostly complete.
Key exclusion criteria (5 listed)
- Pathological type is non-epithelial ovarian cancer.
- Underwent fertility-preserving surgery or palliative surgery.
- Presence of infection during PET/CT image acquisition.
- Concurrent other malignant tumors.
- Severe diseases of other major organs.
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 |
|---|---|---|
| Radio-scoreA score based on the LASSO regression model predicting the R0 resection of the primary debulking surgery of advanced ovarian cancer. | Diagnostic test | SYSU cohort, ZJCH cohort |
Primary outcome
R0 resection
Time frame: yes or not
In patients with advanced ovarian cancer, the residual status after initial cytoreductive surgery is defined as follows: complete resection is defined as R0 resection, whereas visible residual tumor lesions during surgery are defined as non-R0 resection
3 secondary outcomes
5-year progression-free survival (PFS)
Time frame: 5 years
5-year overall survival (OS)
Time frame: 5-year
Response to platinum-based chemotherapy
Time frame: At least 6 months after the last chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Results publication: PubMed 11870167Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248.
- Results publication: PubMed 30022629Feng Z, Wen H, Jiang Z, Liu S, Ju X, Chen X, Xia L, Xu J, Bi R, Wu X. A triage strategy in advanced ovarian cancer management based on multiple predictive models for R0 resection: a prospective cohort study. J Gynecol Oncol. 2018 Sep;29(5):e65. doi: 10.3802/jgo.2018.29.e65. Epub 2018 Apr 23.
- Results publication: PubMed 30413383Vergote I, Coens C, Nankivell M, Kristensen GB, Parmar MKB, Ehlen T, Jayson GC, Johnson N, Swart AM, Verheijen R, McCluggage WG, Perren T, Panici PB, Kenter G, Casado A, Mendiola C, Stuart G, Reed NS, Kehoe S; EORTC; MRC CHORUS study investigators. Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials. Lancet Oncol. 2018 Dec;19(12):1680-1687. doi: 10.1016/S1470-2045(18)30566-7. Epub 2018 Nov 6.
- Results publication: PubMed 28209497Suidan RS, Ramirez PT, Sarasohn DM, Teitcher JB, Iyer RB, Zhou Q, Iasonos A, Denesopolis J, Zivanovic O, Long Roche KC, Sonoda Y, Coleman RL, Abu-Rustum NR, Hricak H, Chi DS. A multicenter assessment of the ability of preoperative computed tomography scan and CA-125 to predict gross residual disease at primary debulking for advanced epithelial ovarian cancer. Gynecol Oncol. 2017 Apr;145(1):27-31. doi: 10.1016/j.ygyno.2017.02.020. Epub 2017 Feb 14.
- Results publication: PubMed 20113693Chereau E, Ballester M, Selle F, Cortez A, Darai E, Rouzier R. Comparison of peritoneal carcinomatosis scoring methods in predicting resectability and prognosis in advanced ovarian cancer. Am J Obstet Gynecol. 2010 Feb;202(2):178.e1-178.e10. doi: 10.1016/j.ajog.2009.10.856.
- Results publication: PubMed 35979992Wang J, Liu L, Pang H, Liu L, Jing X, Li Y. Preoperative PET/CT score can predict incomplete resection after debulking surgery for advanced serous ovarian cancer better than CT score, MTV, tumor markers and hematological markers. Acta Obstet Gynecol Scand. 2022 Nov;101(11):1315-1327. doi: 10.1111/aogs.14442. Epub 2022 Aug 18.
- Results publication: PubMed 29702969Palomar Munoz A, Cordero Garcia JM, Talavera Rubio MDP, Garcia Vicente AM, Pena Pardo FJ, Jimenez Londono GA, Soriano Castrejon A, Aranda Aguilar E. Value of [18F]FDG-PET/CT and CA125, serum levels and kinetic parameters, in early detection of ovarian cancer recurrence: Influence of histological subtypes and tumor stages. Medicine (Baltimore). 2018 Apr;97(17):e0098. doi: 10.1097/MD.0000000000010098.
- Results publication: PubMed 36412681Dondi F, Albano D, Bellini P, Camoni L, Treglia G, Bertagna F. Relationship between Baseline [18F]FDG PET/CT Semiquantitative Parameters and BRCA Mutational Status and Their Prognostic Role in Patients with Invasive Ductal Breast Carcinoma. Tomography. 2022 Oct 27;8(6):2662-2675. doi: 10.3390/tomography8060222.
- Derived from this study: PubMed 42351290Ye D, Lin S, Shao Z, Liu Y, Wu B, Huo C, Xu D, Pang SW, Huang C, Li J, Liu J, Wang L, Zhu T, Lu H. The optimal SVM model from multi-model comparison outperforms conventional criteria in preoperative prediction of ovarian cancer residual disease. J Ovarian Res. 2026 Jun 25. doi: 10.1186/s13048-026-02176-w. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
huaiwu Lu principal investigator
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Image, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huaiwu Lu (86+ 18688395806, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection (time frame: yes or not). 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 NCT06533709, which also lists 9 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 1 Aug 2024.