Serum Immunological Profiles in Head and Neck Cancer Pati... | NCT03325036

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

NCT03325036

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Dec 4, 2025Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Head and Neck Cancers Patients

Interventions

Serum levels of immunologic profiles

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Dec 30, 2024Actual

Completion Date

Dec 30, 2024Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Oct 25, 2017

First Posted Date

Oct 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum levels of immunologic profiles	Diagnostic Test	Serum levels of immunologic profiles before and after chemoradiotherapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jenny Ling-Yu Chen, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided