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

NCT06315270 | Not Yet Recruiting DMC

• 1 other identifier: 24K040-001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epithelial Ovarian Cancer; Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Keywords

TCR; Immunological monitoring

Outcome Measures

Primary Outcomes (1)

• Analysis of TCR genealogy data

  1. Analysis of TCRα and TCRβ profile profiles in advanced EOC patients before initial treatment; 2. Analysis of differences in diversity of TCRα and TCRβ profiles in advanced EOC patients before treatment, after completion of treatment and at relapse; 3. Analysis of longitudinal TCR profiles revealing the stability and individual specificity of the immune profiles; 4. 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 5. Differential analysis of dynamic changes in TCRα profile and TCRβ profile in correlation with patients' clinical outcomes

  5 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Gynaecological cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

advanced EOC

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

zhentong wei, doctor

CONTACT

15804300686; zhentongwei2009@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): March 20, 2029
• Study Completion (Estimated): March 20, 2029
• Last Updated: April 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share