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

NCT02489084 | Recruiting

• 1 other identifier: RT2011-03
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Head and Neck neoplasms; Genome-wide association study; Polymorphism, single nucleotide; Toxicity

Outcome Measures

Primary Outcomes (4)

• Change in acute toxicity

  Dysphagia; mucositis; salivary dysfunction; xerostomia

  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

  At 6,12,18,24,36,48,60 months after last day of completion of treatment

• Change in patient-rated symptoms

  Assessed by questionnaires

  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

  At 6,12,18,24,36,48,60 months after last day of completion of treatment

Interventions

Blood sampling OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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

You may not qualify if:

• Prior radiotherapy

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

A.P.G. Crijns, Dr.

CONTACT

+31503610039; a.p.g.crijns@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: July 2, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

NL (1)