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A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Advanced Thyroid Cancer Patients (TOPICS-THYROID)
Bu çalışma, ileri evre tiroid kanseri (thyroid cancer) hastalarında onkogenetik panel testi ile klinik verileri bir araya getiren bir kayıt çalışmasıdır. Çalışmaya, papiller, foliküler, medüller veya anaplastik tiroid kanseri gibi çeşitli tiroid kanseri türleri patolojik olarak doğrulanmış, ileri evre hastalar alınmıştır. Faz uygulanmayan bir kayıt çalışması olarak yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: Cohort A: 1. Pathologically confirmed papillary thyroid carcinoma (PTC). 2. The patient is in advanced stage, which includes recurrent, metastatic, unresectable, or persistent disease. 3. The patients are RAI-refractory\* or ineligible for RAI therapy\*\*. \*The definitions of RAI-refractory are one of the following criteria: no uptake of RAI in the tumor, uptake of RAI in some tumors but no uptake in other tumors, disease progression in spite of RAI uptake in the tumors, or accumulated RAI dose ≥ 600 mCi. \*\*the definitions of ineligible for RAI therapy are one of the following criteria: patients are unable to have RAI therapy due to some reasons, such as not received total thyroidectomy, unable to receive total thyroidectomy, or unable to have self-care in the isolation room. 4. The patient needs systemic therapy. 5. There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed. 6. Age ≥ the legal age. 7. Life expectancy greater than 6 months. 8. Capable of understanding and complying with the protocol requirements and signed informed consent. Cohort B: 1. Pathologically confirmed differentiated thyroid cancer (DTC) other than PTC, which includes follicular thyroid cancer (FTC), Hurthle cell carcinoma, and poorly-differentiated thyroid cancer. 2. The patient is in advanced stage, which includes recurrent, metastatic, unresectable, or persistent disease. 3. The patients are RAI-refractory\* or ineligible for RAI therapy\*\*. \*The definitions of RAI-refractory are one of the following criteria: no uptake of RAI in the tumor, uptake of RAI in some tumors but no uptake in other tumors, disease progression in spite of RAI uptake in the tumors, or accumulated RAI dose ≥ 600 mCi. \*\*the definitions of ineligible for RAI therapy are one of the following criteria: patients are unable to have RAI therapy due to some reasons, such as not received total thyroidectomy, unable to receive total thyroidectomy, or unable to have self-care in the isolation room. 4. The patient needs systemic therapy. 5. There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed. 6. Age ≥ the legal age. 7. Life expectancy greater than 6 months. 8. Capable of understanding and complying with the protocol requirements and signed informed consent. Cohort C: 1. Pathologically confirmed medullary thyroid carcinoma (MTC). 2. The patient is in advanced stage, which includes recurrent, metastatic, unresectable, or persistent disease. 3. There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed. 4. Age ≥ the legal age. 5. Life expectancy greater than 6 months. 6. Capable of understanding and complying with the protocol requirements and signed informed consent. Cohort D: 1. Pathologically confirmed anaplastic thyroid carcinoma (ATC). 2. There are archived tumor samples available and the date of archived tumor sampling must be not more than 5 years from screening date. If there is no archived tumor sample available or the tumor sampling date is more than 5 years from screening date, re-biopsy is needed. If the quality of tumor sample is not fit for NGS oncopanel test, re-biopsy is needed. 3. Age ≥ the legal age. 4. Capable of understanding and complying with the protocol requirements and signed informed consent. Cohort E: The patients who had performed large NGS oncopanel test (ACTOnco) previously meet all the inclusion criteria of cohort A, B, C or D except the criteria of archived tumor sample requirement. These patients do not need to take archived tumor sample for NGS oncopanel test but need to take archived tumor sample for TERT promoter mutation and peripheral blood sampling. \- Exclusion Criteria: Cohort A: 1. Inability and unwillingness to give informed consent. 2. The patients have no evidence of disease before systemic treatment. 3. The patients have stable residual disease or metastatic disease without progression and do not need systemic therapies. 4. The patients do not intend to have systemic therapies. 5. Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test. 6. The date of archived tumor sampling is more than 5 years from screening date. 7. Patients refuse for collection of clinical data and follow-up. 8. Mental status is not fit for further treatment or data collection. Cohort B: 1. Inability and unwillingness to give informed consent. 2. The patients have no evidence of disease before systemic treatment. 3. The patients have stable residual disease or metastatic disease without progression and do not need systemic therapies. 4. The patients do not intend to have systemic therapies. 5. Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test. 6. The date of archived tumor sampling is more than 5 years from screening date. 7. Patients refuse for collection of clinical data and follow-up. 8. Mental status is not fit for further treatment or data collection. Cohort C: 1. Inability and unwillingness to give informed consent. 2. The patients have no evidence of disease before systemic treatment. 3. Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test. 4. The date of archived tumor sampling is more than 5 years from screening date. 5. Patients refuse for collection of clinical data and follow-p. 6. Mental status is not fit for further treatment or data collection. Cohort D: 1. Inability and unwillingness to give informed consent. 2. Patients do not agree to provide archived tumor samples and blood samples or they do not agree to do tumor biopsy when archived tumor samples are not available or inadequate for NGS oncopanel test. 3. The date of archived tumor sampling is more than 5 years from screening date. 4. Patients refuse for collection of clinical data and follow up. Cohort E: The patients do not meet all exclusion criteria of cohort A, B, C, or D except for providing archived tumor sample. \-