An observational study in Thyroid Cancer, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by National Taiwan University Hospital · Observational
Among 22 studies in Thyroid Neoplasms with a site in Taiwan — 3 open to participants now, 11 under way, 2 of them phase 3. Thyroid Neoplasms · Taiwan.
Among the 22 studies in Thyroid Neoplasms with a site in Taiwan, this one is the 9th largest by enrollment of the 10 observational ones that give a count, is one of 5 that started in 2018, is one of 10 observational ones, and was the 12th registered.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
Browse Thyroid Neoplasms studies →3 of the 22 studies in Thyroid Neoplasms with a site in Taiwan are open now. Recruiting first, the newest first:
National Taiwan University Hospital · Sites in Taiwan
Apollomics Inc. · Sites in Taiwan, United States, Australia and 8 more countries
Ages 18+
Turning Point Therapeutics, Inc. · Sites in Taiwan, United States, Australia and 16 more countries
Ages 12+
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 152 Thyroid Neoplasms studies recruiting now, 96 (63%) set no upper age limit and 27 (18%) stop at 75 or younger; 37 take children under 18; 13 take healthy volunteers.
This study: 20 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 6 · Phase 3 2
First in 2006; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 74 is below the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.
Median enrollment 219 across the 12 interventional studies, 105 across the 10 observational. Of the 10 that completed or were terminated, 3 (30%) have results posted.
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10 of 22 have an industry lead sponsor. The 10 most frequent:
National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
National Taiwan University Hospital has 8 studies filed under Thyroid Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Thyroid Neoplasms with a site in Taiwan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Papillary and follicular thyroid cancers are low-grade endocrine malignancy, and most patients usually received thyroidectomy with ablative radioactive iodine therapy. These patients were followed with thyroid ultrasonography and serial serum thyroglobulin evaluation. Serum thyroglobulin is the pivotal biomarker in survey of possible residual tumor or recurrence of thyroid cancer. Generally, such patients appear to have the higher residual risk of isolated thyroglobulinemia, and postoperative serum thyroglobulin may suggest distant metastases. Low-risk patients with a non-stimulated postoperative serum thyroglobulin was usually defined of less than 0.4 ng/mL or with thyroid hormone withdrawal thyroglobulin of less than 1.0 ng/mL. However, expensive recombinant human TSH (rhTSH) is usually needed to stimulate serum thyroglobulin for detecting local recurrence or distant metastasis. The issue of earlier biological markers for predicting prognosis of thyroid cancer should be raised.
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. A growing evidence suggests that exosomes could be used as biomarkers to be the diagnosis and prognosis of malignant tumors. Exosomes are 40-100 nm diameters, and correspond to the intraluminal vesicles of endosomal multivesicular bodies. Exosomes secreted by cells could micro-molecularly transfer messages between cells, and be the biological markers of cancer. In addition, exosomes could be collected in serum, tissue fluid and urine for diseases follow-up, and urine as the biosample is easier to repeatedly obtain and non-invasive. In this study, the investigators enroll patients with papillary, follicular, and collect the urine samples before operation, immediately after operation, post-operatively. The investigators try to analyze the urinary exosomal proteins to find the early prognostic biological markers in urine via this prospective study.
This pilot study report will explore that urinary exosomal thyroglobulin could be a reliable biological marker to substitute for serum thyroglobulin in the future. Such patient do not need to withdraw thyroid hormone or receive rhTSH stimulation. For patients with thyroid cancer, if they received thyroidectomy with ablative radioactive I-131 therapy, serum thyroglobulin is defined to be cancer biomarker in the course of follow-up. If thyroglobulin cannot be detected in serum, then such patients were suggested to be biochemically complete treatment, independent of the interference of anti-thyroglobulin antibody. Usually, serum thyroglobulin cannot be detected even under expensive rhTSH stimulation in patients of biochemically complete treatment. Therefore, no serial biomarkers could be recorded for evaluation and prediction of cancer recurrence. In this pilot study, urinary exosomal thyroglobulin provides a non-invasive, reproducible, convenient, serial and correct follow-up for patients with thyroid cancer, because the investigators use peptide sequence to quantify the levels of thyroglobulin in urine exosome. Significant reduction in cost-spending in rhTSH consumption, and patients do not need to stop using thyroid hormone during the course of cancer follow-up. In recent years, the progress of peptides mass spectrometry provided a cost-effective, correct and new pathway for the discovery of biomarkers. Large profiling of proteomics of human urine reveled different follow-up manners. In the viewpoints of oncology, one option is to find new biomarkers for earlier diagnosis of various cancers, and the other is to make a breakthrough for follow-up residual tumor and cancer recurrence. The goal of our pilot study is trying to find the new pathway for tracking the biomarker in patients with thyroid cancer receiving ablative surgery and radioactive I-131 treatment.
The investigators will enroll 150 post-operative patients with papillary, follicular or anaplastic thyroid cancer, and collect their 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.
Inclusion Criteria:diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer, post-operation follow up
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Exclusion Criteria:
Prognostic biological markers via this prospective study
The study was designed as prospective pattern, and the investigators enrolled thyroid cancer with follow-up, then urine exosome protein will be measured and reported. 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. Such biomarkers including thyroglobulin, galectin-3, Calprotectin A8, Calprotectin A9, TKT, Annexin II, Afamin, Keratin 8, Keratin 9, Angiopoietin-1 and TIMP will be measured.
Time frame: 3 years
Plan to share: No
Ran from Aug 2018 to primary completion in Jul 2023, 59 months.
Of 103 non-industry observational studies under Thyroid Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 311. This study's 59 months is below that.
Counting every sponsor, half of 112 studies reached it within 63 months; a quarter within 26 and three quarters within 311.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital →