NCT03000738

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

December 20, 2016

Last Update Submit

March 30, 2017

Conditions

Lymphoma,Non-HodgkinDiffuse Large B Cell LymphomaPeripheral T-Cell Lymphoma

Keywords

CD16- monocyte/CD16+ monocyte ratioCytoDiff flow cytometric systemDiffuse Large B Cell LymphomaPeripheral T-Cell Lymphomaprognosis

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Secondary Outcomes (1)

  • progression free survival

    3 years

Study Arms (1)

non-hodgekin lymphoma

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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(-)
  • years old to 80 years old

You may not qualify if:

  • other tumors
  • severe infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 21606957BACKGROUND

  • Ziegler-Heitbrock L, Ancuta P, Crowe S, Dalod M, Grau V, Hart DN, Leenen PJ, Liu YJ, MacPherson G, Randolph GJ, Scherberich J, Schmitz J, Shortman K, Sozzani S, Strobl H, Zembala M, Austyn JM, Lutz MB. Nomenclature of monocytes and dendritic cells in blood. Blood. 2010 Oct 21;116(16):e74-80. doi: 10.1182/blood-2010-02-258558. Epub 2010 Jul 13.

    PMID: 20628149BACKGROUND

  • Subimerb C, Pinlaor S, Lulitanond V, Khuntikeo N, Okada S, McGrath MS, Wongkham S. Circulating CD14(+) CD16(+) monocyte levels predict tissue invasive character of cholangiocarcinoma. Clin Exp Immunol. 2010 Sep;161(3):471-9. doi: 10.1111/j.1365-2249.2010.04200.x.

    PMID: 20636398BACKGROUND

  • Heagerty PJ, Lumley T, Pepe MS. Time-dependent ROC curves for censored survival data and a diagnostic marker. Biometrics. 2000 Jun;56(2):337-44. doi: 10.1111/j.0006-341x.2000.00337.x.

    PMID: 10877287BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, T-Cell

Study Officials

  • Daobin Zhou, MD

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Wei Zhang

CONTACT

+86-010-69151235vv1223@vip.sina.com

Xiao Han

CONTACT

+86 18618191308xiaoer020@vip.sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 31, 2017

Record last verified: 2017-03