NCT02489084

Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	Blood sampling

Timeline

• Start date: 2013-09-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2015-07-02
• Last updated: 2024-03-01

Locations

1 site across 1 country: Netherlands