Objective:The aim of our study is to obtain a collection of head and neck squamous cell carcinomas that is well characterized for relevant clinical parameters, including follow-up.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The obtained material and information will be stored and employed for future
validation and prognostic studies.
Secondary outcome
NA
Background summary
The survival of head and neck squamous cell carcinoma (HNSCC) patients has
improved only minimally during the last three decades. In particular, patients
with advanced disease (stage III and IV), comprising about 60% of the patient
population, have a poor prognosis. Treatment options for this group are surgery
followed by radiotherapy, radiotherapy alone and a combination of chemo- and
radiotherapy (*chemoradiation*), sometimes followed by salvage surgery. A
proportion of patients do respond to cytotoxic treatment, for a variable length
of time. Study of tumor material from a large group of HNSCC patients to
improve diagnosis and therapy is warranted.
Study objective
Objective:
The aim of our study is to obtain a collection of head and neck squamous cell
carcinomas that is well characterized for relevant clinical parameters,
including follow-up.
Study design
This is a longitudinal study in which tumor material in subsequent patient
order and the clinical information regarding this material will be gathered.
Sampling will last for five years. The tissues will be used in the future for
additional marker studies. The maximal storage time will be 25 years.
Study burden and risks
Extra tumor biopsies will be taken during the diagnostic work-up or a biopsies
will be taken from the tumor when resected. Also a sample of venous blood will
be obtained preoperatively. There is no direct benefit for the participant. The
material collected will be essential for future studies that have the aim to
identify tumor markers causally linked to the process of carcinogenesis and/or
that are able to predict survival. These tumor markers have great future impact
when used for early detection and tailored therapy.
de Boelelaan 1117
Amsterdam 1081HV
NL
de Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
1. Patients must have a histologically proven HNSCC, a squamous cell carcinoma from the oral cavity, oro- or hypopharynx, larynx and cervical part of oesophagus.
2. Patients must have sufficient knowledge of the Dutch language to understand the meaning of the study as described in the patient information.
3. Patients must have the mental capacity to understand the meaning of the study as described in the patient information patient information.
4. Patients must give written informed consent.
5. Age of the patients should be >18. An upper limit of age will not be applied. Elderly patients who are fit enough to undergo surgery in the head and neck area are not likely to encounter negative effects of the extra procedures that will be applied as part of the study.
Exclusion criteria
The decision of the surgeon that the patients is not suitable for this study (e.g. in case of limited size of the 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 | NL22230.029.08 |