Predicting side effects of radiation in head and neck cancer using genetic markers
Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
University Medical Center Groningen · NCT02489084
This study is testing if looking at certain genetic markers can help predict which patients with head and neck cancer might experience swallowing problems after radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Groningen) |
| Trial ID | NCT02489084 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how single nucleotide polymorphisms (SNPs) can enhance predictive models for radiation-induced side effects, particularly dysphagia, in patients with head and neck cancer. By analyzing genetic profiles, the study seeks to improve the understanding of individual radiosensitivity and the risk of complications following radiotherapy. Participants will undergo blood sampling to assess their SNP profiles, which may lead to more personalized treatment approaches. The study focuses on patients receiving curative radiotherapy and aims to fill a gap in current knowledge regarding genetic determinants of treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed head and neck cancer who are of Northern European ethnicity and are undergoing curative radiotherapy.
Not a fit: Patients who have previously received radiation therapy in the head and neck area will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored radiotherapy plans that minimize side effects and improve quality of life for head and neck cancer patients.
How similar studies have performed: While the use of SNPs in predicting treatment outcomes is an emerging field, this specific approach to improve predictive models for radiation-induced side effects in head and neck cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior radiotherapy
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Study coordinator: A.P.G. Crijns, Dr.
- Email: a.p.g.crijns@umcg.nl
- Phone: +31503610039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer, Head and Neck neoplasms, Genome-wide association study, Polymorphism, single nucleotide, Toxicity