The aim of this study is to study whether the symptom pain is a diagnostic marker for a cutaneous squamous cell carcinoma.
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain as a diagnostic marker for cutaneous squamous cell carcinoma
Secondary outcome
Studying the relation between pain and penetration depth (histology) of
squamous cell carcinoma.
Studying the relation between pain and perineural invasion (histology) of
squamous cell carcinoma.
Background summary
Organ transplant recipients have an increased risk to develop warts and skin
malignancies. Due to the multiplicity of the tumors (several hundreds) it could
be very difficult to distinguish benign, premalign and malign skin lesions.
Under dermatologist it is presumed that pain is clinical symptom of squamous
cell carcinoma, although this has never been confirmed by scientific research.
Study objective
The aim of this study is to study whether the symptom pain is a diagnostic
marker for a cutaneous squamous cell carcinoma.
Study design
For every biopsied lesion in organ transplant recipients a questionnaire about
pain will be filled in.
The time to fill in the questionnaire will take approximately 3-5 minutes.
Study burden and risks
The care during our specialized clinic for organ transplant recipients will be
continued exactly the same way as before the start of the study. When lesions
should be biopsied we will ask some additional questions about pain with the
help of the questionnaire.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
1)Only organ-transplant recipients (OTR).
2)All excised skin or biopsied skin lesions (medical reason, cosmetic reason etc.).
3)From one patient more than one tumor can be taken per visit and assessments on later visits are possible. ALL biopsies should be included!! For each biopsy a new ACCESS form has to be filled in.
Exclusion criteria
lack of consent
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 | NL28380.058.09 |