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NCT06315270Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
11 Mar 2024
Start date
20 Mar 2024
Primary completion date
20 Mar 2029
Lead sponsor
The First Hospital of Jilin University
NCT number
NCT06315270

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 20 Mar 2024 to the primary completion date, 20 Mar 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Neoadjuvant chemotherapy patients;
  • Patients with contraindications to radiotherapy;
  • Long-term use of recombinant human erythropoietin, recombinant human interleukin, Ricodin tablets and other drugs affecting the composition of blood cells;
  • Have received immunosuppressive therapy within 2 weeks;

Other illness

  • Vaccination within 2 months; antibiotics for infection within 2 weeks; history of blood transfusion within 2 weeks;
  • 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;
  • Suffering from blood clotting disorders.

Other

  • Splenectomy patients;
  • 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;
  • Severe organ dysfunction;

Who the study is looking for

  • 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;

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.