- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02862470
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
July 2, 2021 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
22
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The investigators will enroll the newly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer.
After signing inform consent, the investigators will collect their urine samples before operation, immediately after operation, post-operative 3, 6 12 months (5 times in one patient).
Description
Inclusion Criteria:
- Newly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer
Exclusion Criteria:
- Thyroid papillary, follicular and anaplastic thyroid cancer with prior operation, chemotherapy, or isotope treatment, or target therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prognostic biological markers via this prospective study.
Time Frame: 2 years
|
Our study was designed as prospective pattern, and the investigators enrolled new thyroid cancer with follow-up, then detect urine exosome and proteins.
The investigators try to find the correlation of outcome ( including recurrence, lymph nodes metastasis..) together with unknown/fresh biomarkers in this study and time-dependent manner.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2016
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
August 24, 2020
Study Registration Dates
First Submitted
July 27, 2016
First Submitted That Met QC Criteria
August 5, 2016
First Posted (Estimate)
August 11, 2016
Study Record Updates
Last Update Posted (Actual)
July 6, 2021
Last Update Submitted That Met QC Criteria
July 2, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201512110RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Cancer
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H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
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