To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Epithelial Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Analysis of TCR genealogy data [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06315270 · 24K040-001