Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data

NCT06533709 | Recruiting DMC

• 1 other identifier: SYSKY-2024-503-01
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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 combined with radiomics.

Conditions

Ovarian Cancer; Image; Predation

Keywords

Ovarian Cancer; PET-CT Image; Debulking Prediction Model

Outcome Measures

Primary Outcomes (1)

• 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

  yes or not

Secondary Outcomes (3)

• 5-year progression-free survival (PFS)

  5 years

• 5-year overall survival (OS)

  5-year

• Response to platinum-based chemotherapy

  At least 6 months after the last chemotherapy

Study Arms (2)

SYSU cohort

Patients cohort from Sun Yat-sen Memorial Hospital, as the training cohort.

Diagnostic Test: Radio-score

ZJCH cohort

Patients cohort from Zhejiang Cancer Hospital, as the external validation cohort.

Diagnostic Test: Radio-score

Interventions

Radio-score DIAGNOSTIC_TEST

A score based on the LASSO regression model predicting the R0 resection of the primary debulking surgery of advanced ovarian cancer.

SYSU cohort; ZJCH cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

The Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 520120, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 11870167 RESULT

• Feng 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.

  PMID: 30022629 RESULT

• Vergote 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.

  PMID: 30413383 RESULT

• Suidan 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.

  PMID: 28209497 RESULT

• Chereau 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.

  PMID: 20113693 RESULT

• Wang 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.

  PMID: 35979992 RESULT

• Palomar 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.

  PMID: 29702969 RESULT

• Dondi 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.

  PMID: 36412681 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Predatory Behavior

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; Appetitive Behavior; Behavior, Animal; Behavior; Consummatory Behavior

Study Officials

• huaiwu Lu

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaiwu Lu

CONTACT

86+ 18688395806; luhuaiwu@mail.sysu.edu.cn

Dongdong Ye

CONTACT

86+ 15218054426; yedd3@mail2.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)