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…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
Toxiciteit radiotherapie in hoofd-halskanker patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be RTOG grade 2 or higher late dysphagia.
Secondary outcome
The secundary endpoints will be RTOG grade 2 or higher acute dysphagia; acute
mucositis; tube feeding dependency; salivary dysfunction (flow); RTOG grade 2-4
acute/late xerostomia; osteoradionecrosis; hypothyroidism; patient-rated head
and neck cancer symptoms (EORTC QLQ-H&N35) and; QoL (EORTC QLQ-C30).
Background summary
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 radiation-oncology, normal tissue
complication probability (NTCP) models based on dose-volume parameters are
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.
Study objective
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.
Study design
Prospective non-randomized observational cohort study.
Study burden and risks
Since April 2007 all HNC patients are subjected to a standardized follow up
program in which all endpoints are (prospectively) assessed on a routine basis
and blood is routinely withdrawn every visit. From all these patients
additional informed consent will be obtained for the purpose of genome wide SNP
profiling. For the purpose of this project 10 ml EDTA blood of all HNC patients
still alive will be obtained for DNA isolation to perform genome wide SNP
association studies. DNA that is left after performing SNP profiling will be
stored for validation studies and/or future research. In addition, 10 ml extra
EDTA blood (plasma + buffy coat), 8.5 ml serum blood and a 2.5 ml RNA tube will
be collected from the patients for the purpose of validation studies and/or
further research. Informed consent from all patients will be obtained to store
patient material for future (validation) studies. This SNP study will be linked
to the SFP in patients with HNC. Patients will be recruited during the standard
follow up visits at the department of Radiation Oncology. It is anticipated
that all patients can be recruited within 12 months. Given the low extra burden
for patients (four (extra) blood collection tubes) the accrual is expected to
be high (approximately 90%). For most patients blood sample collection can be
done simultaneously during blood sample collection for regular check for
thyroid function or during the regular blood sample collection prior to
radiotherapy, so no extra punctures are required. The samples will be stored in
management of LifeLines.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
1. Histological proven head and neck cancer;
2. Primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx,
paranasal sinuses, and/or salivary glands;
3. Treatment with curative intent with primary or postoperative radiotherapy
either or not combined with systemic treatment;
4. Northern European ethnicity (ethnicity is a known confounder in SNP
association studies);
5. Willing and able to comply with the study prescriptions;
6. 18 years or older;
7. No prior radiation (in the head and neck area);
8. Patients must have sufficient knowledge of the Dutch language to understand
the meaning of the study as described in the patient information;
9. Have given written informed consent before patient registration.
Exclusion criteria
Prior radiotherapy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37151.042.12 |