NCT03488134

Predicting Prognosis and Recurrence of Thyroid Cancer Via New Biomarkers, Urinary Exosomal Thyroglobulin and Galectin-3

Completed Last updated 19 March 2024

What this trial tests

trial in Thyroid Cancer in 74 participants. Completed in 20 February 2024.

Timeline

3 August 2018

Primary endpoint
31 July 2023

20 February 2024

Quick facts

Lead sponsor	National Taiwan University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	74
Start date	3 August 2018
Primary completion	31 July 2023
Estimated completion	20 February 2024
Sites	1 location across Taiwan

Conditions studied

• Thyroid Cancer — all drugs for Thyroid Cancer →

Sponsor

National Taiwan University Hospital

Who can join

Adults 20 to 80, any sex, with Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although thyroid cancers are low-grade endocrine malignancy, most patients usually received thyroidectomy with ablative radioactive iodine therapy. Such patients were followed with thyroid ultrasonography and serial serum thyroglobulin evaluation. 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. Therefore, the investigators try to find the biological markers and therapeutic targets via the exosomal expression in urine. On the continuing basis of prior ATC cells culture experiments.

Exosomes are nanovesicles secreted into extracellular environments. Cancer cell-derived exosomes could be found in plasma, saliva, urine and other body fluid of patients with cancer. The investigators try to analyze the urinary exosomal proteins, including thyroglobulin and galectin-3, to find the early prognostic biological markers in urine via this prospective study.

The investigators expected to enroll 150 post-operative patients with papillary, follicular or anaplastic thyroid cancer, and collect the urine samples in outpatient clinic per year. The investigators will analyze the urine exosomal proteins and probable biological markers, including thyroglobulin and galectin-3. The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic and follow-up pathway for such patients with well-differentiated or anaplastic thyroid cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regulation of cargo selection in exosome biogenesis and its biomedical applications in cancer.
   Lee YJ, Shin KJ, Chae YC. · · 2024 · cited 196× · PMID 38580812 · DOI 10.1038/s12276-024-01209-y
2. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
   Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
3. Synergies in exosomes and autophagy pathways for cellular homeostasis and metastasis of tumor cells.
   Salimi L, Akbari A, Jabbari N, Mojarad B, et al · · 2020 · cited 102× · PMID 32426106 · DOI 10.1186/s13578-020-00426-y
4. Clinical applications for exosomes: Are we there yet?
   Perocheau D, Touramanidou L, Gurung S, Gissen P, et al · · 2021 · cited 101× · PMID 33751579 · DOI 10.1111/bph.15432
5. Extracellular vesicles as cancer liquid biopsies: from discovery, validation, to clinical application.
   Zhao Z, Fan J, Hsu YS, Lyon CJ, et al · · 2019 · cited 79× · PMID 30882822 · DOI 10.1039/c8lc01123k
6. Organically derived exosomes as carriers of anticancer drugs and imaging agents for cancer treatment.
   Srivastava A, Rathore S, Munshi A, Ramesh R. · · 2022 · cited 59× · PMID 35192929 · DOI 10.1016/j.semcancer.2022.02.020
7. Progress in extracellular vesicle biology and their application in cancer medicine.
   Srivastava A, Amreddy N, Pareek V, Chinnappan M, et al · · 2020 · cited 46× · PMID 32131140 · DOI 10.1002/wnan.1621
8. Urinary Exosomal Thyroglobulin in Thyroid Cancer Patients With Post-ablative Therapy: A New Biomarker in Thyroid Cancer.
   Huang TY, Wang CY, Chen KY, Huang LT. · · 2020 · cited 39× · PMID 32612576 · DOI 10.3389/fendo.2020.00382