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Trial record 23 of 1278 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

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

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ClinicalTrials.gov Identifier: NCT02489084
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
A.P.G. Crijns, University Medical Center Groningen

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.


Condition or disease Intervention/treatment
Head and Neck Cancer Other: Blood sampling

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
Study Start Date : September 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489084


Contacts
Contact: A.P.G. Crijns, Dr. +31503610039 a.p.g.crijns@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: A.P.G. Crijns, Dr.    +31503610039    a.p.g.crijns@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen

Responsible Party: A.P.G. Crijns, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02489084     History of Changes
Other Study ID Numbers: RT2011-03
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by A.P.G. Crijns, University Medical Center Groningen:
Head and Neck neoplasms
Genome-wide association study
Polymorphism, single nucleotide
Toxicity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms