if at least 50% of the obtained tumor samples will be viable and proliferating after 14 days (i.e. proliferation rate at day 14 is at least 50% of the proliferation rate at day 0), the ex vivo model will be considered as feasible
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
viable tumor tissue after 6 days ex vivo culturing
Secondary outcome
not applicable
Background summary
Prognosis in head and neck cancer has not improved significantly and remains
poor for patients with locally advanced disease, despite intensive treatment.
We developed a method to determine the degree of genomic instability of tumors.
Using mRNA expression patterns of 407 head and neck squamous cell carcinomas
(HNSCC), we demonstrated that HNSCCs are highly instable compared to normal
mucosa and that there is a wide range in genomic instability between tumors. In
normal cells, a high degree of genomic instability results in apoptosis. We
identified genes which overexpression is highly correlated with genomic
instability. We hypothesize that overexpression of these genes is a coping
strategy to survive genomic instability. Inhibition of these targets therefore
may have a potent antitumor activity. We would like to evaluate the clinical
relevance of these targets in head and neck cancer in an ex vivo model, using
patient derived tumor tissue. Therefore feasibility of the ex vivo model should
be tested in HNSCC.
Study objective
if at least 50% of the obtained tumor samples will be viable and proliferating
after 14 days (i.e. proliferation rate at day 14 is at least 50% of the
proliferation rate at day 0), the ex vivo model will be considered as feasible
Study design
prospective collection of fresh tumor tissue to test feasibility of an ex vivo
tumor model
Study burden and risks
no significant additional burden or risks are to be expected when additional
0.5 cm3 tumor tissue is removed during routine surgical resection or staging
endoscopy under general anaesthesia in which diagnostic biopsies are routinely
taken.
Patients do not derive benefit prom participation in this study. We hope that
this study contributes to development of new treatment strategies for future
patients.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Strong suspicion of or proven carcinoma of the oral cavity, pharynx or larynx.
- > 18 yrs of age
- Planned routine biopsy or planned surgical resection as part of standard
diagnostic work-up or treatment
- expected tumor volume > 2 cm3
- informed consent
Exclusion criteria
- non-squamous cell carcinoma after definitive histological analysis
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 | NL51862.042.15 |