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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02885623
Other study ID # 001
Secondary ID
Status Recruiting
Phase N/A
First received August 23, 2016
Last updated October 10, 2017
Start date August 2016
Est. completion date August 2021

Study information

Verified date October 2017
Source Saint Vincent's Hospital, Korea
Contact Jeong-A Kim, MD, Ph.D
Phone 82-31-249-8456
Email jakimapril@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the clinical significance of CX3CR1-expressing myeloid and lymphoid cells in patients of hematologic malignancy.

Tumor cells either express membrane molecules or release tumor-derived soluble factors able to alter myelopoiesis and lymphopoiesis. Myeloid cells expressing CD11b play a critical role in sustaining cancer progression. Also, the fractalkine (CX3CL1; Fkn)/CX3CR1 axis plays an important function in the pathophysiology of various forms of cancers. Fkn is the only known ligand for CX3CR1, and it triggers recruitment of CX3CR1-positive cells through its unique receptor, CX3CR1. Therefore, the investigators focused the prognostic significance of CD11b+ myelo-monocytic cells expressing CX3CR1 and CD3+ lymphoid cells expressing CX3CR1 in the clinical outcomes of newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) and Multiple myeloma (MM).


Description:

Bone marrow aspirates will be obtained from newly diagnosed MM and DLBCL patients at the time of diagnosis and relapse. Peripheral blood will be obtained at the time of diagnosis, finishing treatment, 3 months after treatment and relapse.

The investigators will analyze the cell fractions of CD11b+ CX3CR1+ cells and CD3+CX3CR1+ cells in blood samples by flowcytometry. The investigators will find out the relationship between the tested cells and clinical outcome in MM and DLBCL.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2021
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject newly diagnosed multiple myeloma.

- Subject newly diagnosed diffuse large B cell lymphoma.

Exclusion Criteria:

- History of other hematologic malignancy

- History of previous chemotherapy

Study Design


Locations

Country Name City State
Korea, Republic of The Catholic University of Korea, St.Vincent's hospital Suwon-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression free survival 3 years
Secondary overall survival 3 years
Secondary Death 3 years
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