Head and Neck Cancers PatientsNCT03325036
Serum Immunological Profiles in Head and Neck Cancer Patients Receiving Curative Radiotherapy
An observational study of Head and Neck Cancers Patients, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Cancers Patients
- What is being tested?
- Serum levels of immunologic profiles
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2017to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Serum levels of immunologic profiles before and after chemoradiotherapy will be prospectively evaluated.
Who may be able to join
- Patients with head and neck cancer receiving curative radiotherapy in NTUH radiation therapy department.
Who cannot join
- Patients with head and neck cancer NOT receiving curative radiotherapy in NTUH radiation therapy department.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Head and Neck Cancers Patients
- Being tested
- Serum levels of immunologic profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum levels of immunologic profilesDiagnostic test
Serum levels of immunologic profiles before and after chemoradiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Tumor local recurrence or distant metastasis
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Jul 2017
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancers PatientsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny Ling-Yu Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325036
- Sponsor's protocol ID
- 201706046RINC
- Status last verified
- Jul 2017
- First submitted
- 24 Oct 2017
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Immunological Profiles in Head and Neck Cancer Patients Receiving Curative Radiotherapy: Quantitative Analysis and Prognostic Implication
- ClinicalTrials.gov ID
- NCT03325036
- Acronym / sponsor ID
- 201706046RINC
- Conditions
- Head and Neck Cancers Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Serum levels of immunologic profiles before and after chemoradiotherapy will be prospectively evaluated.
Key inclusion criteria (1 listed)
- Patients with head and neck cancer receiving curative radiotherapy in NTUH radiation therapy department.
Key exclusion criteria (1 listed)
- Patients with head and neck cancer NOT receiving curative radiotherapy in NTUH radiation therapy department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum levels of immunologic profilesSerum levels of immunologic profiles before and after chemoradiotherapy | Diagnostic test | – |
Primary outcome
Disease progression
Time frame: Three years
Tumor local recurrence or distant metastasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Ling-Yu Chen, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancers Patients, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.