Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05463107 |
Other study ID # |
202110076RINB |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2022 |
Est. completion date |
July 31, 2028 |
Study information
Verified date |
March 2024 |
Source |
National Taiwan University Hospital |
Contact |
CHIH-YUAN WANG, Doctor |
Phone |
+886-2-23123456 |
Email |
cyw1965[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Thyroid cancer is the most common endocrine malignancy in the world. Generally, thyroid
cancer could be divided into well-differentiated and poorly-differentiated.
Well-differentiated thyroid cancers usually have two different patterns, including papillary
thyroid cancer and follicular thyroid cancer. Thyroid sonography is convenient to obtain
repeatedly for the images of nodular goiter. However, cytology and pathology are still the
golden rules to make the final diagnosis. Under the basis of sono-guided fine needle
aspiration cytology, diagnosis of papillary thyroid cancer is typically using fine needle
aspiration cytology based on the presentation of typical cytologic features. On the other
hand, thyroid follicular lesion cannot be interpretated via cytology because the evidence of
capsular invasion or vascular permeation of capsule will not be available in fine needle
aspiration cytology. Surgical intervention with pathological specimens is the only pathway to
make the final diagnosis. Interestingly, both patterns of well-differentiated thyroid cancer
shared the same follow-up tumor marker, i.e. serum thyroglobulin. Up to date, pre-operative
diagnosis of follicular thyroid cancer is still one of the unresolved issues in endocrine
oncology.
Description:
Thyroid cancer is one of the most popular malignancy in the past several decades all over the
world. For poorly-differentiated thyroid cancer, therapeutic strategy of costly target
therapy together with immune therapy will be the pivotal one because of its poor prognosis.
The average 5-year relative survival rate of anaplastic thyroid cancer is only 3 to 31 % on
the stage from distant metastasis to localized disease.
However, it will be very different for well-differentiated thyroid cancer, and the average
5-year relative survival rate of both thyroid papillary or follicular thyroid cancer is more
than 98 %. Therefore, the most important treatment strategy for endocrinologists will
consider the development of biomarkers for early diagnosis and postoperative follow-up,
rather than measuring serum thyroglobulin alone, which is the only biomarker in the current
medical guidelines, and there is no choice. Our research team tried to find the newer
biomarker together with serum thyroglobulin for post-operative longitudinal follow-up of
well-differentiated thyroid cancer in the past five years. The investigators used urinary
exosomal proteins as target and did find several peptides to be helpful, including our
published urinary exosomal thyroglobulin (UExTg). In Taiwan, goiter and thyroid cancer are
prevalent diseases. Although papillary thyroid cancer could be diagnosed via reliable
sono-guided fine needle aspiration cytology, follicular thyroid cancer is still an unresolved
issue in daily medical practice, especially in cytology. the investigators need to find a
practicably earlier biomarker, which should be convenient, non-invasive and repeatable in
sample collection. In our previous research and published data, urine will be a reliable
source of data.
Exosomes are nano-vesicles, containing DNA, RNA and proteins, and usually secreted by cells
into extracellular spaces. Generally, the vesicles of exosomes are only 40 to 150 nm in
diameter. Exosomes may carry and transfer the messages between different tissues. Now, the
existing evidences revealed that exosomes may represent certain messages from malignant
cells, including diagnosed biomarkers or prognostic predictors. Previously, published data of
exosomal studies in thyroid cancer focused on serum microRNA, long coding RNA and circular
RNA, but only few published data on peptides, which were named as liquid biopsy. However,
cell-secreted exosomes of malignancy could be collected not only in plasma, body fluid, but
also from urine, which is the non-invasive pathway but valuable wastes of human body. Our
research group had developed experienced technique to collect urinary exosomes via our pilot
study in the past several years.
Since the investigators proved the role of urinary exosomal thyroglobulin, UExTg, in
post-operative follow-up in well-differentiated thyroid cancer in the past three years, from
2018-2020, the investigators also found several peptides to be the candidates of prognostic
predictors in our preliminary studies, including Calprotectin A8/A9, Annexin-2,
Angiopoietin-1.