To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer

Not yet recruiting

• Conditions: Epithelial Ovarian Cancer; Stage IV Ovarian Cancer; Stage III Ovarian Cancer

• Registration Number: NCT06315270
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

This project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of TCR diversity with clinical outcomes and the potential role of TCR profiling in cancer prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-18
• Study Start: 2024-03-20
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01
• Primary Completion: 2029-03-20
• Study Completion: 2029-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Newly diagnosed patients with advanced EOC, 18-75 years of age: including patients with preoperative assessment of stage III-IV EOC, who underwent initial tumour cytoreduction and 6-8 courses of postoperative chemotherapy with paclitaxel + carboplatin/docetaxel + carboplatin;
• Eastern Cooperative Oncology Group (ECOG) physical strength status (PS) score of 0 or 1;
• Cooperation in the treatment process by providing clinicopathological data and imaging data required for the study process;
• Cooperate with follow-up visits and collection of node blood for clinical efficacy assessment, and agree to use the test data for subsequent research and product development.
• The initial and follow-up treatment processes are in accordance with NCCN guidelines;

Exclusion Criteria

• Neoadjuvant chemotherapy patients;
• Splenectomy patients;
• Patients with contraindications to radiotherapy;
• Any other patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study;
• Unacceptable or unavailable means of assessing specified efficacy such as imaging;
• Vaccination within 2 months; antibiotics for infection within 2 weeks; history of blood transfusion within 2 weeks;
• Long-term use of recombinant human erythropoietin, recombinant human interleukin, Ricodin tablets and other drugs affecting the composition of blood cells;
• Severe organ dysfunction;
• Infectious diseases such as immunodeficiency syndrome, active tuberculosis, HIV infection, and other infectious diseases not suitable for participation;
• Pre-cancerous diseases of the blood, such as myelodysplastic syndromes;
• Have received immunosuppressive therapy within 2 weeks;
• Suffering from blood clotting disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of TCR genealogy data	5 years	1. Analysis of TCRα and TCRβ profile profiles in advanced EOC patients before initial treatment; 2. Analysis of differences in diversity of TCRα and TCRβ profiles in advanced EOC patients before treatment, after completion of treatment and at relapse; 3. Analysis of longitudinal TCR profiles revealing the stability and individual specificity of the immune profiles; 4. correlation of TCRα and TCRβ profiling diversity with levels of tumour markers (ca125, ca199, CEA, HE-4) and imaging findings under continuous monitoring to explore their value in monitoring tumour treatment response; 5. Differential analysis of dynamic changes in TCRα profile and TCRβ profile in correlation with patients' clinical outcomes