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

NCT04434833 | Unknown

• 1 other identifier: NHL-scRNA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (4)

• Extra nodal involvement

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

  At enrollment

• Complete response rate

  After 6 cycles of treatment (each cycle 21 to 28 days)

• Overall response rate

  After 6 cycles of treatment (each cycle 21 to 28 days)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The tissue puncture specimens patients with both lymph node and extra nodal involvement, or patients at high risk of relapse, or patients receiving a novel target drug treatment will be obtained and restored for single-cell RNA sequencing. The clinical significance of single-cell RNA sequencing results will be explained combined with the clinical data provided by Ruijin Hospital.

You may qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao, M.D. and PhD

CONTACT

13512112076; zhao.weili@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director of Shanghai Institute of Hematology

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 17, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (1)