CX3CR1 ProteinNCT02885623
Role of CX3CR1-expressing Cells in Hematologic Malignancy
An observational study of CX3CR1 Protein and Diffuse Large B Cell Lymphoma, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CX3CR1 Protein, Diffuse Large B Cell Lymphoma, Multiple Myeloma
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: newly diagnosed multiple myeloma patients newly diagnosed diffuse large B cell lymphoma patients
Who may be able to join
- Subject newly diagnosed multiple myeloma.
- Subject newly diagnosed diffuse large B cell lymphoma.
Who cannot join
- History of other hematologic malignancy
- History of previous chemotherapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, St.Vincent's hospital
Suwon, Gyeonggi-do, #16247
Jeong-A Kim, MD, Ph.D, 82-31-249-8456, jakimapril@gmail.com
Jeong-A Kim, MD, Ph.D
About this study
Official title: Clinical Significance of CX3CR1 Adhesion Molecule-expressing Myeloid and Lymphoid Cells in Hematologic Malignancy
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).
Read the detailed 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.
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 3 years
Secondary outcomes (2)
overall survival
Measured: 3 years
Death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CX3CR1 ProteinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-A Kim, Saint Vincent's Hospital, Korea
- Investigators
- Jeong-A Kim, MD, Ph.D, Principal investigator, Saint Vincent's Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885623
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2017
- First submitted
- 23 Aug 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of CX3CR1 Adhesion Molecule-expressing Myeloid and Lymphoid Cells in Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT02885623
- Acronym / sponsor ID
- 001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- newly diagnosed multiple myeloma patients newly diagnosed diffuse large B cell lymphoma patients
Key inclusion criteria (2 listed)
- Subject newly diagnosed multiple myeloma.
- Subject newly diagnosed diffuse large B cell lymphoma.
Key exclusion criteria (2 listed)
- History of other hematologic malignancy
- History of previous chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression free survival
Time frame: 3 years
2 secondary outcomes
overall survival
Time frame: 3 years
Death
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-A Kim, MD, Ph.D principal investigator
Saint Vincent's Hospital, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CX3CR1 Protein and Diffuse Large B Cell Lymphoma, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-A Kim, MD, Ph.D (82-31-249-8456, jakimapril@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.