The Value and Mechanisms for Monocytes Subpopulations in Predicting the Prognosis of Lymphomas

• Conditions: Peripheral T-Cell Lymphoma; Lymphoma,Non-Hodgkin; Diffuse Large B Cell Lymphoma

• Registration Number: NCT03000738
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio could help predict the prognosis of DLBCL and PTCL.

Detailed Description

The investigators plan to prospectively involve 100 non-hodgekin lymphoma patients, including 50 diffuse large B cell lymphomas and 50 peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital.

The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review.

All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by enhanced computed tomography or PET-CT.

The peripheral blood would be collected. The Cytodiff flow cytometric technique would be used to test 16 leukocyte subpopulations from peripheral blood at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression.

Progression-free survival (PFS) and overall survival (OS) would be estimated using the Kaplan-Meier method and two-tailed log-rank test.The Cox proportional hazards model would evaluate prognostic factors for OS and PFS. Specificity, sensitivity and cut-off would be established using time-dependent receiver operating characteristic (ROC) curve analysis. Area under curve (AUC) values \>0.7 indicate that the parameter can be used for diagnosis, with values \>0.9 indicating high clinical accuracy.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-22
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL, DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL, HSTL)
2. no treatment before
3. hCG(-)
4. 18 years old to 80 years old

Exclusion Criteria

1. other tumors
2. severe infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
progression free survival	3 years