Head and Neck CancerHANSNCT02489084
Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
An observational study of Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background of the study: Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major impact on the general dimensions of quality of life (QoL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Blood sampling
- How many people
- 2,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients ≥18 years still alive and treated since April 2007 for HNC at the department of Radiation Oncology of the UMCG, Groningen, the Netherlands
Who may be able to join
- Histological proven head and neck cancer
- Primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinuses, and/or salivary glands
- Treatment with curative intent with primary or postoperative radiotherapy either or not combined with systemic treatment
- Northern European ethnicity (ethnicity is a known confounder in SNP association studies)
- Willing and able to comply with the study prescriptions
- 18 years or older
Show all 9Show fewer
- No prior radiation (in the head and neck area)
- Patients must have sufficient knowledge of the Dutch language to understand the meaning of the study as described in the patient information
- Have given written informed consent before patient registration
Who cannot join
- Prior radiotherapy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9700RB
About this study
Background of the study:
Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major impact on the general dimensions of quality of life (QoL). In radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume parameters being used to determine the risk of acute and late RISE. NTCP models containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may improve model performance and thus enable more individualized radiotherapy. Information of the predictive value of SNPs or SNP signatures among patients with HNC is currently not available.
Read more
Objective of the study:
The main objective of this project will be to test the hypothesis that SNP profiles can improve the performance of predictive models for the most frequently reported late RISE, i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of life.
- Conditions
- Head and Neck Cancer
- Being tested
- Blood sampling
- Keywords
- Head and Neck neoplasms, Genome-wide association study, Polymorphism, single nucleotide, Toxicity
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute toxicity
Dysphagia; mucositis; salivary dysfunction; xerostomia
Measured: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Change in late toxicity
Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism
Measured: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Change in patient-rated symptoms
Assessed by questionnaires
Measured: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Change in patient-rated Quality-of-Life
Assessed by questionnaires
Measured: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startSep 2013
- Primary completionJan 2026
- Study completionJan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489084
- Sponsor's protocol ID
- RT2011-03
- Acronym
- HANS
- Status last verified
- Feb 2024
- First submitted
- 19 May 2015
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
- ClinicalTrials.gov ID
- NCT02489084
- Acronym / sponsor ID
- HANS / RT2011-03
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck neoplasms, Genome-wide association study, Polymorphism, single nucleotide, Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2026 (actual)
- Study completion
- Jan 2026 (actual)
- First posted
- 2 Jul 2015 (estimated)
- 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.
Background of the study:
Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major impact on the general dimensions of quality of life (QoL). In radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume parameters being used to determine the risk of acute and late RISE. NTCP models containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may improve model performance and thus enable more individualized radiotherapy. Information of the predictive value of SNPs or SNP signatures among patients with HNC is currently not available.
Objective of the study:
The main objective of this project will be to test the hypothesis that SNP profiles can improve the performance of predictive models for the most frequently reported late RISE, i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients ≥18 years still alive and treated since April 2007 for HNC at the department of Radiation Oncology of the UMCG, Groningen, the Netherlands
Key inclusion criteria (9 listed)
- Histological proven head and neck cancer
- Primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinuses, and/or salivary glands
- Treatment with curative intent with primary or postoperative radiotherapy either or not combined with systemic treatment
- Northern European ethnicity (ethnicity is a known confounder in SNP association studies)
- Willing and able to comply with the study prescriptions
Key exclusion criteria (1 listed)
- Prior radiotherapy
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 |
|---|---|---|
| Blood sampling | Other | – |
Primary outcome
Change in acute toxicity
Time frame: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Dysphagia; mucositis; salivary dysfunction; xerostomia
Change in late toxicity
Time frame: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism
Change in patient-rated symptoms
Time frame: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Assessed by questionnaires
Change in patient-rated Quality-of-Life
Time frame: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Assessed by questionnaires
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 6 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 9 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 6 Aug 2026. 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 Netherlands. 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?
Change in acute toxicity (time frame: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy). The study lists 4 primary outcomes in all. 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 6 Aug 2026.