Clinical Trial: Anaplastic Thyroid Cancer and Follicular Thyroid Cancer-derived Exosomal Analysis Via Treatment of Lovastatin and Vildagliptin and Pilot Prognostic Study Via Urine Exosomal Biological Markers in Thyroid Cancer Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]
Official Title: Anaplastic Thyroid Cancer and Follicular Thyroid Cancer-derived Exosomal Analysis Via Treatment of Lovastatin and Vildagliptin and Pilot Prognostic Study Via Urine Exosoma
Brief 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.
Detailed Summary: 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 na
Sponsor: National Taiwan University Hospital
Current Primary Outcome: Prognostic biological markers via this prospective study. [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Taiwan University Hospital
Dates:
Date Received: July 27, 2016
Date Started: August 2016
Date Completion: July 2020
Last Updated: August 5, 2016
Last Verified: August 2016
