Clinical trial NCT06315270: To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epithelial Ovarian Cancer
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Keywords: TCR
Immunological monitoring
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advanced EOC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of TCR genealogy data
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
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Study officials:
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