Myeloid-derived Suppressor Cells (MDSCs) in OSCC Patients

May 10, 2020 updated by: National Taiwan University Hospital

Myeloid-derived Suppressor Cells (MDSCs) Detection Before and After Beta-glucan Administration in Oral Squamous Cell Carcinoma Patients

Oral squamous cell carcinoma (OSCC) has the highest annual increase in the rate of death among the top 10 leading cancers in Taiwan. This research aimed to explore whether increased anti-tumor immunity for OSCCs reduces the recurrence rate or improves survival. We first identified CD33+/CD11b+/HLA-DR-/low/CD14+/- as myeloid-derived suppressor cell (MDSC) surface markers by using flow cytometry to compare the MDSC frequency of OSCCs with blood samples from healthy donors (HDs). We then re-confirmed the suppression of T cell proliferation and function achieved by co-culturing with OSCC-educated MDSCs. We subsequently explore whether using particulate β-glucan as a food-grade supplement promotes the human immune system via subversion of immune modulatory MDSCs. Lastly, we correlated clinicopathological parameters with MDSCs and β-glucan administration to examine anti-tumor immunity, and to predict the therapeutic effect and prognosis in OSCC patients..

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Oral squamous cell carcinoma (OSCC) has the highest annual increase in the rate of death among the top 10 leading cancers in Taiwan. This research aimed to explore whether increased anti-tumor immunity for OSCCs reduces the recurrence rate or improves survival. We first identified CD33+/CD11b+/HLA-DR-/low/CD14+/- as myeloid-derived suppressor cell (MDSC) surface markers by using flow cytometry to compare the MDSC frequency of OSCCs with blood samples from healthy donors (HDs). We then re-confirmed the suppression of T cell proliferation and function achieved by co-culturing with OSCC-educated MDSCs.

Clinically, we enrolled 100 OSCC patients and 30 HDs to demonstrate a significantly higher MDSC frequency in OSCC candidates than HDs. To determine whether using β-glucan as a food-grade supplement promotes the immune system of OSCC patients, we further allocated OSCC patients with and without pre-surgical administration of whole glucan particle β-glucan to groups II and III, respectively (with group I being the HDs).

We will explore whether using particulate β-glucan as a food-grade supplement promotes the human immune system via subversion of immune modulatory MDSCs. Lastly, we correlated clinicopathological parameters with MDSCs and β-glucan administration to examine anti-tumor immunity, and to predict the therapeutic effect and prognosis in OSCC patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Oral squamous cell carcinoma (OSCC) subjects without other cancer diagnosis
  • healthy donors (HDs)

Exclusion Criteria:

  • pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: OSCC subjects with β-glucan supplement
Oral squamous cell carcinoma subjects with pre-surgical administration of whole glucan particle β-glucan
Dietary supplement: β-glucan
β-glucan, a biological response regulator, derived from yeast has been known for more than 45 years, and has anti-infective and anti-tumor activities. β-glucan is a molecule with a β-1,3-linked D-glucose backbone and β-1,6-linked side chains. Thus far, at least 4 receptors for β-glucan have been discovered in humans, which are surface antigens associated with macrophages or myeloid precursor cells as complement receptor 3 (CR3; CD11b/CD18, Mac-1, αMβ2 integrin) (Vetvicka et al. 1996; Xia et al. 1999), lactosylceramide (Zimmerman et al. 1998), scavenger receptor (Rice et al. 2002) and dectin-1 (Brown et al. 2003; Taylor et al. 2007; Saijo et al. 2007).
No Intervention: Healthy donors
healthy donors without pre-surgical administration of whole glucan particle β-glucan
No Intervention: OSCC subjects without β-glucan supplement
Oral squamous cell carcinoma subjects without pre-surgical administration of whole glucan particle β-glucan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
recurrence-free survival rate or overall survival rate
Time Frame: 2 years
This research aimed to explore whether particulate β-glucan as a crucial preoperative adjuvant increasing anti-tumor immunity for OSCCs reduces the recurrence rate or improves survival. Clinically, we enrolled 100 OSCC patients and 30 HDs, and further allocated OSCC patients with and without pre-surgical administration of whole glucan particle β-glucan to groups II and III, respectively (with group I being the HDs). we correlated clinicopathological parameters with MDSCs and β-glucan administration to examine anti-tumor immunity, and to evaluate recurrence-free survival rate or overall survival rate in OSCC patients.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shih-Jung Cheng, DDS, PhD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201701065RIPB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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