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

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315270
• Other study ID #: 24K040-001
• Status: Not yet recruiting
• Start date: March 20, 2024
• Est. completion date: March 20, 2029

Study information

• Verified date: January 2024
• Source: The First Hospital of Jilin University
• Contact: zhentong wei, doctor
• Phone: 15804300686
• Email: zhentongwei2009[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 20, 2029
• Est. primary completion date: March 20, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms
• Recurrence
• Stage III Ovarian Cancer
• Stage IV Ovarian Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of TCR genealogy data	Analysis of TCRa and TCRß profile profiles in advanced EOC patients before initial treatment; Analysis of differences in diversity of TCRa and TCRß profiles in advanced EOC patients before treatment, after completion of treatment and at relapse; Analysis of longitudinal TCR profiles revealing the stability and individual specificity of the immune profiles; correlation of TCRa and TCRß 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; Differential analysis of dynamic changes in TCRa profile and TCRß profile in correlation with patients' clinical outcomes	5 years