Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02862470 |
| Other study ID # |
201512110RINB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 5, 2016 |
| Est. completion date |
August 24, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The investigators expected to enroll 30 patients with papillary, follicular or anaplastic
thyroid cancer, and collect their urine samples before operation, immediately after
operation, post-operative 3, 6 12 months. The investigators will analyze the urine exosomal
proteins and probable biological markers. The investigators hope to find the prognostic
biological markers via this prospective study. The investigators further hope to find newly
therapeutic mechanism and medications for such patients with poorly-differentiated or
anaplastic thyroid cancer.
Description:
Although papillary and follicular thyroid cancers are low-grade endocrine malignancy, they
were fatal if the cancer cells were poorly-differentiated or anaplastic change. Prior
researches indicated that one-third well-differentiated thyroid cancers could transform to
poorly-differentiated patterns, even to be anaplastic thyroid cancer (ATC), a fatal
malignancy, and no effective therapeutic strategies was noted, including surgical
intervention, chemotherapy and radiotherapy. The poorly-differentiated or anaplastic change
of thyroid cancer cells proliferates rapidly and always invades local tissues with distant
metastasis. Cellular de-differentiation is the most pivotal cause for malignant
transformation and invasion. De-differentiation usually in papillary thyroid cancer and
follicular thyroid cancer, and definitely in ATC. The Poorly-differentiated thyroid cancer
cell will rapidly proliferate and metastasize. The poorly-differentiated tumor cells lost
apoptotic mechanism with de-differentiation, and such phenomenon is fatal for such patients.
The investigators started research of thyroid cancer since 1999, and the investigators
initially found TNF-α could induce cyto-morphological re-differentiation of thyroid cancer
cells. Later, the investigators further found Lovastatin could induce re-differentiation of
anaplastic thyroid cancer (ATC) cells in 25μM, but induce apoptosis in 50μM, in 2001. In
2006, the investigators designed nude mice model, and found tumor will shrink via treatment
of Lovastatin in 5 or 10 mg/kg/day, but tumor will proliferate significantly in 1 mg/kg/day.
The investigators called this phenomenon as "Duality effects" of statins. In 2012, the
investigators found FLOT1 and transketolase (TKT) as important regulatory factor of
re-differentiation and proliferation in ATC cells, respectively. The investigators also found
that inhibition of Dipeptidyl peptidase-4 (CD26) will influence proliferation of ATC cells.
Exosomes are nanovesicels secreted into extracellular environments. A growing evidence
suggests theat exosomes could be used as biomarkers to be the diagnosis and prognosis of
malignant tumors. Exosomes are 50-100 nm diameters, and correspond to the intrluminal
vesicles of endosomal multivesicular bodies. Because of their cellular orgins, exosomes have
specific protein markers, like CD63, CD9, CD81 and heat shock protein (HSP). Urine was used
to be the biosamples in the past five years in baldder cancer, prostate cancer, breast cancer
and ovarian cancer. Urine sample is usually easy to obtain and non-invasive. Exosomes
secreted by cells could micro-molecularly transfer messages between cells and to be
biological markers of cancer. The investigators now found Vildagliptin and Lovastatin could
influence tumor cells survival via exosomal proteins. For patients of thyroid cancer, the
investigators could obtain the urine samples without invasive procedures. Furthermore, the
investigators could find the biological markers and therapeutic targets via the exosomal
expression in urine. On the continuing basis of ATC cells culture experiments, the
investigators expected to enroll 30 patients with papillary, follicular or anaplastic thyroid
cancer, and collect their urine samples before operation, immediately after operation,
post-operative 3, 6 12 months. The investigators will analyze the urine exosomal proteins and
probable biological markers. The investigators hope to find the prognostic biological markers
via this prospective study. The investigators further hope to find newly therapeutic
mechanism and medications for such patients with poorly-differentiated or anaplastic thyroid
cancer.
