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NCT Number: NCT06315270

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Analysis of TCR genealogy data

    Time frame: 5 years

    • Analysis of TCRα and TCRβ profile profiles in advanced EOC patients before initial treatment;
    • Analysis of differences in diversity of TCRα and TCRβ 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 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
    • Differential analysis of dynamic changes in TCRα profile and TCRβ profile in correlation with patients' clinical outcomes

Study contacts

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

zhentong wei, doctor

CONTACT

[email protected]

15804300686

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2024
Registry last updated
Apr 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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