Myeloid-derived Suppressor Cells (MDSCs) in OSCC Patients
Primary Purpose
Squamous Cell Carcinoma of the Oral Cavity
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
β-glucan
Sponsored by
About this trial
This is an interventional prevention trial for Squamous Cell Carcinoma of the Oral Cavity focused on measuring myeloid-derived suppressor cell (MDSC), oral squamous cell carcinoma (OSCC), whole glucan particle (WGP) β-glucan, flow cytometry, recurrence, prognosis
Eligibility Criteria
Inclusion Criteria:
- Oral squamous cell carcinoma (OSCC) subjects without other cancer diagnosis
- healthy donors (HDs)
Exclusion Criteria:
- pregnant woman
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
No Intervention
No Intervention
Arm Label
OSCC subjects with β-glucan supplement
Healthy donors
OSCC subjects without β-glucan supplement
Arm Description
Oral squamous cell carcinoma subjects with pre-surgical administration of whole glucan particle β-glucan
healthy donors without pre-surgical administration of whole glucan particle β-glucan
Oral squamous cell carcinoma subjects without pre-surgical administration of whole glucan particle β-glucan
Outcomes
Primary Outcome Measures
recurrence-free survival rate or overall survival rate
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04387682
First Posted
May 4, 2020
Last Updated
May 10, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04387682
Brief Title
Myeloid-derived Suppressor Cells (MDSCs) in OSCC Patients
Official Title
Myeloid-derived Suppressor Cells (MDSCs) Detection Before and After Beta-glucan Administration in Oral Squamous Cell Carcinoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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..
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Oral Cavity
Keywords
myeloid-derived suppressor cell (MDSC), oral squamous cell carcinoma (OSCC), whole glucan particle (WGP) β-glucan, flow cytometry, recurrence, prognosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Oral squamous cell carcinoma (OSCC) subject and healthy donors (HDs) subject
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OSCC subjects with β-glucan supplement
Arm Type
Other
Arm Description
Oral squamous cell carcinoma subjects with pre-surgical administration of whole glucan particle β-glucan
Arm Title
Healthy donors
Arm Type
No Intervention
Arm Description
healthy donors without pre-surgical administration of whole glucan particle β-glucan
Arm Title
OSCC subjects without β-glucan supplement
Arm Type
No Intervention
Arm Description
Oral squamous cell carcinoma subjects without pre-surgical administration of whole glucan particle β-glucan
Intervention Type
Dietary Supplement
Intervention Name(s)
β-glucan
Intervention Description
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).
Primary Outcome Measure Information:
Title
recurrence-free survival rate or overall survival rate
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Oral squamous cell carcinoma (OSCC) subjects without other cancer diagnosis
healthy donors (HDs)
Exclusion Criteria:
pregnant woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Jung Cheng, DDS, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
27183652
Citation
Albeituni SH, Ding C, Liu M, Hu X, Luo F, Kloecker G, Bousamra M 2nd, Zhang HG, Yan J. Correction: Yeast-Derived Particulate beta-Glucan Treatment Subverts the Suppression of Myeloid-Derived Suppressor Cells (MDSC) by Inducing Polymorphonuclear MDSC Apoptosis and Monocytic MDSC Differentiation to APC in Cancer. J Immunol. 2016 May 1;196(9):3967. doi: 10.4049/jimmunol.1600346. No abstract available.
Results Reference
result
PubMed Identifier
15905548
Citation
Allendorf DJ, Yan J, Ross GD, Hansen RD, Baran JT, Subbarao K, Wang L, Haribabu B. C5a-mediated leukotriene B4-amplified neutrophil chemotaxis is essential in tumor immunotherapy facilitated by anti-tumor monoclonal antibody and beta-glucan. J Immunol. 2005 Jun 1;174(11):7050-6. doi: 10.4049/jimmunol.174.11.7050.
Results Reference
result
PubMed Identifier
12719478
Citation
Brown GD, Herre J, Williams DL, Willment JA, Marshall AS, Gordon S. Dectin-1 mediates the biological effects of beta-glucans. J Exp Med. 2003 May 5;197(9):1119-24. doi: 10.1084/jem.20021890. Epub 2003 Apr 28.
Results Reference
result
PubMed Identifier
27696591
Citation
Chen WC, Lai CH, Chuang HC, Lin PY, Chen MF. Inflammation-induced myeloid-derived suppressor cells associated with squamous cell carcinoma of the head and neck. Head Neck. 2017 Feb;39(2):347-355. doi: 10.1002/hed.24595. Epub 2016 Oct 3.
Results Reference
result
PubMed Identifier
19197294
Citation
Gabrilovich DI, Nagaraj S. Myeloid-derived suppressor cells as regulators of the immune system. Nat Rev Immunol. 2009 Mar;9(3):162-74. doi: 10.1038/nri2506.
Results Reference
result
PubMed Identifier
22437938
Citation
Gabrilovich DI, Ostrand-Rosenberg S, Bronte V. Coordinated regulation of myeloid cells by tumours. Nat Rev Immunol. 2012 Mar 22;12(4):253-68. doi: 10.1038/nri3175.
Results Reference
result
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Myeloid-derived Suppressor Cells (MDSCs) in OSCC Patients
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