NCT04387682|UnknownDMC
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Sponsor study identifier
interventional
130
1 country
1
Study Start
March 22, 2017
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
March 21, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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..
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 21, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2017
Actual (reported)December 31, 2019
Actual (reported)May 4, 2020
Actual (reported)May 14, 2020
Actual (reported)March 21, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Taiwan University Hospital
Taipei, 100, Taiwan
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.
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.
Shih-Jung Cheng, DDS, PhD
National Taiwan University Hospital
130 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2020
First Posted
May 14, 2020
Study Start
March 22, 2017
Actual (reported)Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
March 21, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 14, 2020
Record last verified: 2020-04
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