NCT02489084Completed
Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2000 (actual)
- First submitted
- 19 May 2015
- Start date
- 1 Sept 2013
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Head and neck cancer
- NCT number
- NCT02489084
What you commit to
- Study type: Observational
- Participants enrolled: 2000
- From 1 Sept 2013 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.