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NCT Number: NCT06533709

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 520120, China

Location status: Recruiting

Location contact

huaiwu Lu

CONTACT

[email protected]

86+ 18688395806

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 5-year progression-free survival (PFS)

    Time frame: 5 years

    PFS was calculated from the date of the last chemotherapy until disease progression or death due to any cause.

  2. 5-year overall survival (OS)

    Time frame: 5-year

    OS was calculated from the date of the primary debulking surgery until death due to any cause.

  3. Response to platinum-based chemotherapy

    Time frame: At least 6 months after the last 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongdong Ye

CONTACT

[email protected]

86+ 15218054426

Huaiwu Lu

CONTACT

[email protected]

86+ 18688395806

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data and Its Clinical Application

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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