The Value and Mechanisms for Monocytes Subpopulations in... | NCT03000738

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

NCT03000738

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Mar 31, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lymphoma,Non-Hodgkin
Diffuse Large B Cell Lymphoma
Peripheral T-Cell Lymphoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Dec 20, 2016

First Submission Date that Met QC Criteria

Dec 20, 2016

First Posted Date

Dec 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2017

Last Update Posted Date

Mar 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-hodgekin lymphoma		100 non-hodgekin lymphoma patients (age >=18y) without previous treatment would be administered, including 50 DLBCLs and 50 PTCLs.

Interventions

Not provided

Measure	Description	Time Frame
overall survival		3 years

Measure	Description	Time Frame
progression free survival		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)
no treatment before
hCG(-)
18 years old to 80 years old

Exclusion Criteria:

other tumors
severe infections

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed to be diffuse large B cell lymphoma or peripheral T cell lymphoma without any previous treatment in Peking Union Medical College Hospital (PUMCH) would be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Zhang	Contact	+86-010-69151235		vv1223@vip.sina.com
Xiao Han	Contact	+86 18618191308		xiaoer020@vip.sina.com

Overall Officials

Name	Affiliation	Role
Daobin Zhou, MD	Peking Union Medical College Hospital	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21606957	Background	Wilcox RA, Ristow K, Habermann TM, Inwards DJ, Micallef IN, Johnston PB, Colgan JP, Nowakowski GS, Ansell SM, Witzig TE, Markovic SN, Porrata L. The absolute monocyte and lymphocyte prognostic score predicts survival and identifies high-risk patients in diffuse large-B-cell lymphoma. Leukemia. 2011 Sep;25(9):1502-9. doi: 10.1038/leu.2011.112. Epub 2011 May 24.
20628149

ID	Term
D008228	Lymphoma, Non-Hodgkin
D016403	Lymphoma, Large B-Cell, Diffuse
D016411	Lymphoma, T-Cell, Peripheral

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders