Thyroid CancerNCT03488134
Predicting Prognosis and Recurrence of Thyroid Cancer Via New Biomarkers, Urinary Exosomal Thyroglobulin and Galectin-3
An observational study of Thyroid Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 74 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2018to 20 Feb 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- Unclearly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Predicting Prognosis and Recurrence of Thyroid Cancer Via New Biomarkers, Urinary Exosomal Thyroglobulin and Galectin-3
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.
Read the detailed description
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.
- Conditions
- Thyroid Cancer
- Keywords
- Exosome, Anaplastic thyroid cancer, Urine, Biological marker, Thyroglobuin, Galectin-3
- Medical subject headings
- Thyroid Neoplasms, Thyroid Carcinoma, Anaplastic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start3 Aug 2018
- Primary completion31 Jul 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHIH-YUAN WANG, Doctor, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488134
- Sponsor's protocol ID
- 201711082RINA
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2018
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CY, Shih SR, Chen KY, Chung YC, Huang PJ. Long-Term Changes of Urinary Exosomal Peptide Levels After Thyroidectomy in Patients with Thyroid Cancer: A Prospective Observational Study. Int J Nanomedicine. 2024 May 23;19:4667-4677. doi: 10.2147/IJN.S458931. eCollection 2024.
PubMed 38803995Huang TY, Wang CY, Chen KY, Huang LT. Urinary Exosomal Thyroglobulin in Thyroid Cancer Patients With Post-ablative Therapy: A New Biomarker in Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Jun 16;11:382. doi: 10.3389/fendo.2020.00382. eCollection 2020.
PubMed 32612576
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Predicting Prognosis and Recurrence of Thyroid Cancer Via New Biomarkers, Urinary Exosomal Thyroglobulin and Galectin-3
- ClinicalTrials.gov ID
- NCT03488134
- Acronym / sponsor ID
- 201711082RINA
- Conditions
- Thyroid Cancer
- Keywords
- Exosome, Anaplastic thyroid cancer, Urine, Biological marker, Thyroglobuin, Galectin-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Unclearly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic biological markers via this prospective study
Time frame: 3 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 38803995Wang CY, Shih SR, Chen KY, Chung YC, Huang PJ. Long-Term Changes of Urinary Exosomal Peptide Levels After Thyroidectomy in Patients with Thyroid Cancer: A Prospective Observational Study. Int J Nanomedicine. 2024 May 23;19:4667-4677. doi: 10.2147/IJN.S458931. eCollection 2024.
- Derived from this study: PubMed 32612576Huang TY, Wang CY, Chen KY, Huang LT. Urinary Exosomal Thyroglobulin in Thyroid Cancer Patients With Post-ablative Therapy: A New Biomarker in Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Jun 16;11:382. doi: 10.3389/fendo.2020.00382. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHIH-YUAN WANG, Doctor principal investigator
Department of Internal Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic biological markers via this prospective study (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.