Accurately identify the molecular/ biochemical 'fingerprints' of the tissue structures and cell types within normal and malignant mucosa from the oral cavity, in particular the edge of the tongue and the floor of the mouth, based on Raman…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are the characteristic Raman spectra of the tissue
structures and cell types within normal and malignant mucosa from the oral
cavity (in particular the edge of the tongue and the floor of the mouth), as a
reflection of the molecular/ biochemical composition of these tissues.
Secondary outcome
• Determine what the difference is in the molecular/ biochemical *fingerprints*
between the normal-looking mucosa adjacent to the tumor and the normal mucosa
of the contralateral side of the oral cavity.
• Determine what the difference is in the molecular/ biochemical *fingerprints*
between normal and malignant mucosa of the oral cavity.
• Determine what the difference is in the molecular/ biochemical *fingerprints*
between different patients (interpatient variance).
• Determine what the sensitivity and specificity of Raman spectroscopy is,
compared to the gold standard (histological assessment).
• Build a multivariate diagnostic model that can distinguish between normal and
malignant mucosa from the oral cavity
Background summary
Head and Neck Squamous Cell Carcinomas (HNSCC) are associated with severe
disease and high mortality, which is due mainly to the development of
metastases and recurrences over time. It is known that there is a higher chance
to develop metastases and recurrences when the surgical tumor resection is
incomplete. The current gold standard to ensure tumor-free margins during
surgery, histological assessment, is time-consuming and is dependent on the
experience of the surgeon and on subjective assessment of the surgeon and the
pathologist. A new technique is therefore needed that can provide objective
real-time information about the composition of tissues during surgical tumor
resections in the head and neck region.
During tumorigenesis the morphologically visible malignant transformation of an
epithelial cell is preceded by changes in its biochemical composition. Raman
spectroscopy is an optical technique based on inelastic scattering of light by
molecules. The concentration of a specific molecule in a tissue defines its
contribution to the Raman spectrum. Since a Raman spectrum of a single molecule
is very specific for that molecule, a Raman spectrum of a tissue can be seen as
a molecular or biochemical *fingerprint* of that tissue. Because different
types of tissue will vary in their overall molecular composition, their Raman
spectra will also differ. Raman spectroscopy can consequently provide detailed
information on the biochemical composition of specific tissue structures and
cell types.
Raman spectroscopy is a non-destructive and non-invasive technique that needs
no tissue preparation. Moreover, with this technique it is possible to obtain
real-time clinical information about the investigated tissues. Based on these
characteristics Raman spectroscopy is a powerful candidate for in vivo and ex
vivo real-time guidance of oncological surgical resections in head and neck
region.
Study objective
Accurately identify the molecular/ biochemical 'fingerprints' of the tissue
structures and cell types within normal and malignant mucosa from the oral
cavity, in particular the edge of the tongue and the floor of the mouth, based
on Raman spectroscopy, in order to make a first step towards in vivo
applications of this technique.
Study design
- prospective collection of tissue samples
- observational research (Raman mapping experiments)
Study burden and risks
To close the biopsy defects during surgery, none or one soluble suture will be
used. This suture can give some discomfort or pain while eating or speaking,
however it is expected that this will not significantly contribute to the
discomfort related to the clinically indicated resection of the malignant
lesion. Patients are postoperative treated according to a protocol which will
lead to accurate pain management and antiseptic care. Because of this and
because the biopsies will be very small (6 mm cross-cut), the chance of
infection and bleeding is very small.
For future purposes a blood sample will be collected additional to pre- or
post-operation blood control, in order to correlate the results of Raman
spectroscopy with molecular diagnostic methods.
There are no risks associated for the patient when the biopsies of the
resection material are collected.
No additional treatments, consults or tests are necessary for the patient.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
• Surgical oncologic procedure because of an untreated SCC of the oral cavity
• Signed informed consent
• Male and female
• Age > 18 years old
• No distant metastasis
Exclusion criteria
• Another type of tumor in the head and neck region (non SCC)
• Pre-operative treatment (chemotherapy or radiotherapy)
• Presence of distant metastases (M1)
• Patients with HIV, CMV or Hepatitis C
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 | NL37340.078.11 |