A Single-cell Transcriptome Study in Patients With Non-Hodgkin's Lymphoma

Non Hodgkin Lymphoma Clinical Trial

Official title:

A Single-cell Transcriptome Study in Patients With Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434833
• Other study ID #: NHL-scRNA
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 2023

Study information

• Verified date: July 2020
• Source: Ruijin Hospital
• Contact: Weili Zhao, M.D. and PhD
• Phone: 13512112076
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using single-cell RNA sequencing, this study will explore the heterogeneity of lymphoma inside and outside the lymph node, identify tumor specific molecular markers and cell subgroups, explore the differences in tumor microenvironment composition, and provide a basis for diagnosis and precision treatment.

Description:

In recent decades, the incidence of lymphoma has been increasing year by year in the world. Non-Hodgkin lymphoma accounts for about 90% of lymphoma, of which the classification is complex and the efficacy is poor compared to Hodgkin's lymphoma. Non-Hodgkin's lymphoma is often associated with the extra nodal involvement, and according to literature, extra nodal lymphoma accounts for 1/3 to 1/2 of all non-Hodgkin lymphomas. Compared with non-Hodgkin's lymphoma without extra nodal involvement, the prognosis of lymphoma with extra nodal involvement was relatively poor. The recurrence rate was higher, and its incidence, histology type, clinical staging and so on all had their own characteristics.

Tumor cells depend to some extent on the interaction with non-tumor cells and matrix components of the tumor microenvironment to maintain survival and proliferation. In addition, the non tumor cells and matrix components can mediate immunosuppressive action to promote tumor escape from immunosurveillance, resulting in disease progression. At the same time, more and more data show that the tumor microenvironment plays a key role in the development of tumor resistance. The cellular composition and spatial properties of the tumor microenvironment show significant heterogeneity, depending on a number of factors, including subtypes of lymphomas and extra nodal sites of lymphomas. Studying the tumor microenvironment will provide rationale for more precise target therapy. Through single-cell RNA sequencing, this study hopes to identify the heterogeneity of nodal and extra nodal lymphoma cells, to understand the differences in tumor microenvironment, and to provide a basis for diagnosis and precision treatment.

There are new target drugs for different antigen targets. But patients may not be sensitive to a certain drug, and the drug is often expensive, resulting in increased financial burden on patients without efficacy. Therefore, the research for biomarkers to predict patient efficacy and prognosis is particularly important.

The treatment efficacy of patients with relapsed lymphoma is often not good, so the prediction and treatment of patients with high-risk of relapsing is a clinical significant problem. On the basis of single-cell transcriptomics, this study hopes to find biomarkers for predicting the relapse of lymphoma and provide new ideas for clinical diagnosis and treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2023
• Est. primary completion date: June 2022
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Patients with pathological confirmed diagnosis of non-Hodgkin's lymphomas.

• Patients with both lymph node and extra nodal involvement, or patients at high risk of relapse, or patients receiving a novel target drug treatment.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extra nodal involvement	Clinical diagnosis of lymphoma invasion in extra nodal organs with or without pathological confirmation	At enrollment
Primary	Complete response rate		After 6 cycles of treatment (each cycle 21 to 28 days)
Primary	Overall response rate		After 6 cycles of treatment (each cycle 21 to 28 days)
Primary	Relapse	Clinical diagnosis of emergence of new lymphoma lesion with or without pathology confirmation	From the achievement of complete response to study completion, an average of 2 years