Myeloid-derived Suppressor Cells (MDSCs) in OSCC Patients

NCT04387682 | Unknown DMC

• 1 other identifier: 201701065RIPB
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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..

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (3)

OSCC subjects with β-glucan supplement

OTHER

Oral squamous cell carcinoma subjects with pre-surgical administration of whole glucan particle β-glucan

Dietary Supplement: β-glucan

Healthy donors

NO INTERVENTION

healthy donors without pre-surgical administration of whole glucan particle β-glucan

OSCC subjects without β-glucan supplement

NO INTERVENTION

Oral squamous cell carcinoma subjects without pre-surgical administration of whole glucan particle β-glucan

Interventions

β-glucan DIETARY_SUPPLEMENT

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).

OSCC subjects with β-glucan supplement

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant woman

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 27183652 RESULT

• 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.

  PMID: 15905548 RESULT

• 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.

  PMID: 12719478 RESULT

• 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.

  PMID: 27696591 RESULT

• 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.

  PMID: 19197294 RESULT

• 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.

  PMID: 22437938 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shih-Jung Cheng, DDS, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Oral squamous cell carcinoma (OSCC) subject and healthy donors (HDs) subject

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 14, 2020
• Study Start: March 22, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 21, 2021
• Last Updated: May 14, 2020

Record last verified: 2020-04

Locations

TW (1)