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

Jilin University

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06315270

24K040-001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.