For head and neck (H&N), lung and esophageal cancer, an initial simple screening test would involve interrogation of the buccal mucosa. There are several tissue alterations related to field carcinogenesis that are currently undetectable but are…
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Brief title
Condition
- Other condition
Synonym
Health condition
Neoplasmata in hoofd-halsgebied, longen en slokdarm
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Optical scattering properties of buccal mucosa will be measured and compared
between patients with and without distant malignancy.
Secondary outcome
Scattering properties will be related to nanostructural changes measured using
electron microscopy on biopsy material (2 mm punch) taken from the site of the
optical measurement.
Background summary
Screening of the general population for early signs of cancer is the key to
reduction of cancer-related death. An excellent novel opportunity for risk
stratification technology development is based on the well-established
phenomenon of field carcinogenesis, dictating that the genetic and
environmental factors that lead to cancer development are not localized, but
instead affect an organ diffusely. An individual*s risk for having cancer could
hypothetically be assessed through the analysis of normal-appearing tissue from
an easily accessible location that is genetically and environmentally related
to the organ.
Study objective
For head and neck (H&N), lung and esophageal cancer, an initial simple
screening test would involve interrogation of the buccal mucosa. There are
several tissue alterations related to field carcinogenesis that are currently
undetectable but are accessible for in vivo, non-invasive optical detection.
Specifically, alterations in cells due to changes in their nanoscale cellular
organization (ultrastructure) have been linked to field carcinogenesis and are
directly correlated to the tissue optical scattering properties. Therefore,
using the light scattering properties of tissues as optical biomarkers of field
carcinogenesis is a potential target for patient friendly screening.
Accurately identify the optical scattering properties of normal appearing
buccal mucosa using MDSFR, in patients with histologically proven primary H&N,
lung and esophageal tumours and of age matched specialism related patiënts not
suspected for cancer in those organs.
Study design
Observational non-randomized cohort study with non-invasive measurements and an
invasive biopsy.
Study burden and risks
The patiënt burden of the optical measurements is low. The lightsource has in
intestity to low to couse any heath-related sensations. The measurement will
not cause pain.
The 2mm bioptie will cause a minor burden for the patiënt. A temporary light
painsensation is to be suspected. The bioptie brings a minor risk of bleading.
If that occurs treatment by compression will be aplied. If necessary a soluble
suture will be placed. The biopty has a very small risk of an infection. If
necessary this will be treated with antibiotics.
Burg. Jacobsplein 51
Rotterdam 3000 CA
NL
Burg. Jacobsplein 51
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:;Patients with cancer:
* Diagnosis of a primary, untreated
1) SCC of the oropharynx or larynx, OR
2) Lung cancer (all types and stages), OR
3) Esophageal cancer (all types and stages)
* Age 18 or over
* Good understanding of Dutch or English;Specialism-related patients not suspected for cancer
* Diagnosis of
1) (Sino)nasal polyps OR nasal septum deviation/anomaly with an extended ENT-physical examination including fiber-optical endoscopy within the last 12 months OR
2) COPD, all stages with a CT-scan within the last 12 months OR
3) Patiënts with complaints of indigestion that underwent endoscopic examination of the esophagus
* Age 50 or over
* Good understanding of Dutch or English
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study if any of the following criteria are met:;*Cancer*-patiënts:
* Prior treatment of the tumor ((chemo)radiation therapy or other)
* Another type of tumor in the head and neck region (non SCC)
* Recurrence of the tumor (no-primary tumor)
* Patients with diagnosed HIV, CMV or Hepatitis C
* Serious other illness;Specialism-related non-malignant patients:
* Any suspection of (pre)malignant laesions at physical examination and clinical tests (e.g. CT-scan and endoscopy)
* Clinical signs of malignancies (e.g. loss of weight and night sweats).
* Patients with diagnosed HIV, CMV or Hepatitis C
* Serious other illness
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 | NL53626.078.15 |