Identify molecular differences in carcinogenesis of LSCC between younger and elderly patients through an integrated proteogenomic analysis of laryngeal tissue biopsies that could optimize personalized treatment of elderly patients in particular.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identify molecular differences in carcinogenesis of LSCC between younger (<70
years) and elderly (>70 years) patients through an integrated proteogenomic
analysis of laryngeal tissue biopsies
Secondary outcome
Investigate whether these molecular differences are associated with patients*
oncological outcome in terms of laryngeal preservation rate, disease-free
survival, disease-specific survival and overall patient survival.
Background summary
With the ageing population, the incidence of laryngeal squamous cell carcinoma
(LSCC) is increasing among elderly. Risk factors for LSCC in elderly are
presumably different from those in younger patients, suggesting a different
molecular mechanism in tumor biology. In addition, biological ageing or frailty
has been related with worse treatment outcomes in patients with LSCC. A panel
of tissue biomarkers could be helpful in the prediction of treatment outcome
and survival of patients from different age categories and to distinguish frail
elderly patients who will respond to invasive treatment from those who will
not.
Study objective
Identify molecular differences in carcinogenesis of LSCC between younger and
elderly patients through an integrated proteogenomic analysis of laryngeal
tissue biopsies that could optimize personalized treatment of elderly patients
in particular.
Study design
This study is a prospective observational study, following a previous pilot
study on protein profiles in tissue biopsies from patients with laryngeal
carcinoma (NL50497.042.14, METc-number: 2014/385). The pilot study was
performed as a proof of principle to test proteogenomics in two small groups of
patients with laryngeal carcinoma (young patients <65 years of age and elderly
patients >75 years of age). In the current study we will extend proteogenomic
analysis (consisting of mass spectrometry and RNA-sequencing) on laryngeal
tissue biopsies, including patients from all age categories. Over a period of
three years, a total of 144 patients will be included. The minimum duration of
follow-up will be two years per included patient. Therefore, the total study
duration is five years.
Study burden and risks
Bleeding, infection and dysfonia could be possible risks of a biopsy, but are
extremely rare (expected incidence < 0.1%). These complications did not occur
during execution of our previous pilot study.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Newly diagnosed squamous cell carcinoma of the larynx
- Age >18 years;
- Written informed consent;
- WHO performance status: 0-2.
Exclusion criteria
- Previous treatment of head and neck cancer;
- Previous radiation therapy in the head and neck area;
- Diagnostic procedure in an emergency situation (e.g. severe dyspnoea);
- Histological diagnosis other than squamous cell carcinoma.
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 | NL62246.042.17 |