- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05463107
Correlation Between Various Urinary Exosomal Protein Biomarkers and Pathological Manifestation in Thyroid Follicular Neoplasm: Early and Pre-operative Diagnosis of Follicular Thyroid Cancer
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: CHIH-YUAN WANG, Doctor
- Phone Number: 265371 +886-2-23123456
- Email: cyw1965@gmail.com
Study Contact Backup
- Name: PEI-JIE HUANG, Bachelor
- Phone Number: 265051 +886-2-23123456
- Email: pylaff1920@gmail.com
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- CHIH-YUAN WANG
- Phone Number: 265371 +886 2 23123456
- Email: cyw1965@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosed patients with nodular goiter or multinodular goiter, thyroid papillary, follicular and anaplastic thyroid cancer, pre-operation.
Exclusion Criteria:
- unclearly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of serum thyroglobulin level
Time Frame: Within 36 months
|
Thyroid function test
|
Within 36 months
|
Change of serum free T4 level
Time Frame: Within 36 months
|
Thyroid function test
|
Within 36 months
|
Change of serum TSH level
Time Frame: Within 36 months
|
Thyroid function test
|
Within 36 months
|
Change of anti-thyroglobulin level
Time Frame: Within 36 months
|
Thyroid function test
|
Within 36 months
|
Urinary exosomal thyroglobulin detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal galectin-3 detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal calprotectin A9 detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal transketolase detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal keratin 19 detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal angiopoietin-1 detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal tissue inhibitor of metalloproteinase detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal keratin 8 detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal calprotectin A8 detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal annexin II detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Urinary exosomal afamin detection
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thyroid fine needle aspiration cytology
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Ultrasonography of thyroid nodules
Time Frame: Within 36 months
|
Urinary exosomal biomarker
|
Within 36 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: CHIH-YUAN WANG, Doctor, Department of Internal Medicine, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202110076RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
-
Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
-
Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Thyroid Gland Medullary Carcinoma | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
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
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States