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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04434833
Collaborator
(none)
150
1
35
4.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Single-cell Transcriptome Study in Patients With Non-Hodgkin's Lymphoma
    Actual Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Extra nodal diseases

    Patients with both lymph node and extra nodal involvement.

    Target drugs

    Patients enrolled in clinical trials of novel target drugs.

    Relapse

    Patients with high risk of relapse.

    Outcome Measures

    Primary Outcome Measures

    1. Extra nodal involvement [At enrollment]

      Clinical diagnosis of lymphoma invasion in extra nodal organs with or without pathological confirmation

    2. Complete response rate [After 6 cycles of treatment (each cycle 21 to 28 days)]

    3. Overall response rate [After 6 cycles of treatment (each cycle 21 to 28 days)]

    4. Relapse [From the achievement of complete response to study completion, an average of 2 years]

      Clinical diagnosis of emergence of new lymphoma lesion with or without pathology confirmation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Ruijin Hospital Shanghai China

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhao Weili, First Deputy Director of Shanghai Institute of Hematology, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT04434833
    Other Study ID Numbers:
    • NHL-scRNA
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Jul 7, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2020