Serum Immunological Profiles in Head and Neck Cancer Patients Receiving Curative Radiotherapy

Serum Immunological Profiles in Head and Neck Cancer Patients Receiving Curative Radiotherapy: Quantitative Analysis and Prognostic Implication

The purpose of the study is to investigate the clinical usefulness of serum levels of immunologic profiles including pro/anti-inflammatory interleukins, other detectable serum biomarkers including transforming growth factor b1 (TGFb1) or soluble major histocompatibility complex Class I chain-related peptide A (sMICA), and leukocyte subpopulations in head and neck cancers patients receiving curative radiotherapy, as prognostic biomarkers for disease recurrence and survival.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancers Patients
• Intervention / Treatment: Diagnostic test: Serum levels of immunologic profiles

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Serum levels of immunologic profiles before and after chemoradiotherapy will be prospectively evaluated.

Description

Inclusion Criteria:

• Patients with head and neck cancer receiving curative radiotherapy in NTUH radiation therapy department.

Exclusion Criteria:

• Patients with head and neck cancer NOT receiving curative radiotherapy in NTUH radiation therapy department.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	Tumor local recurrence or distant metastasis	Three years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jenny Ling-Yu Chen, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 201706046RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No