Clinical trial NCT04068077: Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis
Official title: Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyloidosis
Keywords: optical coherence tomography (OCT)
amyloidosis
pigmented diseases
skin diseases
dermatology
pathology
H&E stain
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Apollo Medical Optics, Ltd
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population from experimental group will be selected.

Brief summary: Amyloidosis is caused by the misfolding protein accumulated in tissue, which affects the function of the organs. In addition to the primary cutaneous amyloidosis, a skin lesion may also appear in another classification - systemic amyloidosis. Physicians can confirm diagnosis of the above classification by skin biopsy.

Primary cutaneous amyloidosis is common in Asia and South America. In Taiwan, 80 people are diagnosed with primary cutaneous amyloidosis in every 100,000 people. Among the disease, macular amyloidosis and lichen amyloidosis are the most common subtypes. Primary cutaneous amyloidosis can cause severe itching, pigmentation, and skin keratosis, and further affect the social behavior of patients. The etiology of primary cutaneous amyloidosis is currently unclear, possibly due to genetic variations or viral infection. Typical primary cutaneous amyloidosis can be diagnosed by clinical manifestations, however, if the location or appearance of a lesion is atypical, the disease will be indistinguishable from other pigmented diseases, and further need a biopsy. If physicians can use a rapider and more accurate assistance tool to evaluate disease first, it will improve the accuracy of clinical diagnosis, relieve patient of suffering from biopsy, and further use medical resources more effectively.

Optical coherence tomography (OCT) is a kind of optical imaging medical system. It generates images by detecting the variations in refractive indexes of the various components in soft tissues. Apollo Medical Optics, Ltd. (AMO)'s OCT device (ApolloVue™ S100 image system, Viper1-S003) acquires real-time in vivo skin tissue tomograms with cellular resolution which provides a non-invasive, non-radioactive and rapid image acquisition.

In this study, AMO's OCT will be used to observe features in tomograms of primary cutaneous amyloidosis and that of other indistinguishable diseases, compare the correspondence of tomograms with pathological sections, induct features in tomograms specific to primary cutaneous amyloidosis and other indistinguishable diseases, and further establish an OCT database of primary cutaneous amyloidosis.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with suspected primary cutaneous amyloidosis and other indistinguishable diseases
* Patients with no open wounds

Exclusion Criteria:

* Patients with a transcutaneous infectious disease
* Patients under the age of 20
* Vulnerable populations, including: pregnant women, handicapped, and homelessness
* Patient cannot cooperate in examination

Primary outcomes:
measure: Number of subjects with clear tissue characteristics of amyloidosis and/or other pigmented diseases in tomograms
timeFrame: 1 year
measure: Number of subjects with the distinction between skin lesion and normal skin in tomograms
timeFrame: 1 year
Secondary outcomes:
measure: Number of subjects with the distinction between amyloidosis and other pigmented diseases in tomograms
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ding-Dar Lee, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
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