Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid...
Differentiated Thyroid CancerGenderLenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.
Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total...
Thyroid CancerEffect of exergaming exercises and mediteranean diet on thyroid cancer patients following total thyroidectomy adult patients from both gender will be randomly assigned equally to exergaming exercises, Mediterranean diet groups using computer-generated block randomization. Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed three times a week, for a total of 12 weeks Group C: Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.PREDIMED questionnaire is used To assess adherence to the Mediterranean diet Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
Study of PET Imaging With 18F-TFB in Patients With Thyroid Cancer
Thyroid CancerThe goal of the study is to evaluate a new imaging test that may allows the investigators to predict the uptake of radioactive iodine by thyroid cancer faster than the current standard and that does not interfere with the uptake of radioactive iodine used for therapy.
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid CancerSomatic mutations in the MAP (mitogen-activated protein) kinase pathway have been found in about 80% of papillary thyroid tumors (PTCs). The evaluation of the PTC mutational profile is crucial for the definition of the prognosis and for predicting the effects of targeted and personalized therapies. Molecular characterization by mass spectrometry (Mass ARRAY) allows the search for multiple mutations in a single experiment, in a sensitive, fast and economic way. A Mass ARRAY platform (PTC-MA) was developed, capable of identifying the presence of the most common somatic point mutations and rearrangements in PTC (Pesenti et al., Endocrine 2017). The aim of the study is to characterize the mutational profile of a large series of papillary thyroid carcinomas (PTC). Tumor samples will be analyzed using our PTC-MA platform. The molecular profile of PTCs will be correlated with the clinical and prognostic characteristics of the patients.
Impact of Conventional Treatments and Clinical Variables on Thyroid Cancer
Thyroid CancerDTC has a generally favorable prognosis. The possibility to discriminate between patients with aggressive tumors and those with a more indolent behavior may reduce the need for unnecessary treatments. Aim of this observational study is to evaluate how anamnestic, clinical, and histopathological variables may influence the outcome of the enrolled patients, both regarding morbidity and mortality and in terms of therapeutic choices. The study aims to evaluate the prognostic impact of the therapeutic interventions in terms of efficacy and regarding the appearance of adverse events.
RFA Treatment for Papillary Thyroid Microcarcinoma
Papillary Thyroid MicrocarcinomaThyroid surgery has always been the mainstay of treatment for thyroid cancer. Thyroid surgery carries a low risk of complications that include recurrent or superior laryngeal nerve injury leading to voice changes, hypoparathyroidism, hypothyroidism with need for thyroid hormone supplementation, and unsightly scarring. Although many patients with thyroid cancer find these risks acceptable, these risks are sometimes less acceptable to patients with benign disease. In an era when the medical field is treating thyroid diseases less aggressively, there is a pressing need to identify approaches to treat indolent malignant disease less invasively. The purpose of this observational study is to evaluate the efficacy and safety of Radiofrequency Ablation (RFA) for treatment of Papillary Thyroid Microcarcinoma (PTMC) in patients that have already agreed to RFA procedure based on treating physician recommendation. This is a data collection study in which we ask participants to give us access to information generated before and after RFA treatment of their condition. The RFA procedure uses image guidance to place an electrode through the skin into the target tumor. In RFA, high-frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion.
Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma...
Differentiated Thyroid CancerLymph Node MetastasesBackground: Despite a favorable prognosis, metastatic cervical lymph nodes (LN), are not uncommon among patients with differentiated thyroid cancer (DTC). Current guidelines recommend that a suspicious cervical LN on neck ultrasound (US) should be investigated with fine needle aspiration biopsy for cytology (FNAC) and for thyroglobulin (Tg) measurement (FNA-Tg), using saline washout of the needle content. Since Tg is a protein produced exclusively by thyroid follicular cells, a positive FNA-Tg result establishes the diagnosis of metastatic DTC. Currently, following LN biopsy, a patient must wait days to weeks to receive results, that directly impacts the treatment plan. This delay may be solved by a point of care assay of the washout Tg (POC-Tg), drawn from a suspicious cervical LN. Another potential novel usage of POC-Tg is the evaluation of suspicious LN found during neck surgery for known or suspicious DTC. Here, the POC-Tg may save the time needed for the completion of 'frozen section'. The study product: POC-Tg is a lateral flow immunoassay for Tg, able to detect within minutes Tg at concentration equal to 5 ng/mL and above (the midrange of the accepted cut-off). Methods: The multi-center validation study will include 100 patients in the FNA clinic, and 150 LN (dissected from 50-150 patients) in the operating room (OR). Each LN will be evaluated using both the formal accepted method (in the FNA clinic, the combination of FNAC and FNA-Tg; and frozen section in the OR), and the novel POC-Tg. Clinical decisions will be made according to the formal evaluation only. In a retrospective analysis, the investigators will estimate the sensitivity and specificity of the POC-Tg and the formal accepted method against the reference ('gold') standard (cytology, histology and follow-up US in the FNA clinic setting, and final histology in the OR setting).
interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT)
Anaplastic Thyroid CancerAnaplastic thyroid cancer has historically proven very difficult to research due to a combination of its rarity and the associated short survival period for those affected. In 2009, 2340 patients in the UK were diagnosed with thyroid cancer with 70-90 expected to be the anaplastic subtype 1,2. For these patients average life expectancy is in the range of 2-6 months with only a very small number surviving for more than one year. It is a highly aggressive form of cancer that is refractory to current treatment options. By collecting tissue and blood samples along with clinical data across the UK we will be able to accumulate numerically significant numbers of samples and data points which will facilitate research opportunities. Researchers will be encouraged to apply for access to the collected samples in order to try and establish the causal mechanisms for disease development, potential therapeutic targets and to relate clinical course and outcome with specific molecular defects. Due to the rarity it is not feasible for a single cancer centre or cancer network to accumulate sufficient samples for research in a meaningful timeframe hence the need for national collaboration in order to try and offer patients with this disease hope in the future. All UK patients with anaplastic thyroid cancer would be potentially eligible. The project is expected to run for at least 15 years and all thyroid cancer clinicians will be encouraged to participate. Patients will be asked to donate surplus thyroid cancer tissue following routine biopsy procedures along with an optional blood sample. 2. Objectives Primary Objectives The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities. There is no direct research question that the project itself addresses at this stage. The research proposals that subsequently arise as a result of this project will be generated by accredited research parties from the UK and potentially internationally. These research proposals will be submitted to the interNational Anaplastic Thyroid Cancer Tissue Bank and Database Project (iNATT) Steering Committee for assessment. As the volume of material collected per patient is expected to be of small volume, by virtue of the specimen comprising core biopsy or fine needle aspirate material, research proposals will need to be prioritised according to the potential benefits the proposed research offers. Priority will be given to projects that may lead to the identification of potential therapeutic targets. Each research proposal will require their own ethical approval and research and development assessments before commencing. The steering committee will be multidisciplinary and will include nationally respected researchers and thyroid cancer clinicians. Scientific Justification The long term objective is to try and address the current lack of understanding about the aetiology and progression of this disease and ultimately to develop new therapeutic interventions that may slow the rate of disease progression, improve quality of life and prolong what is currently a very short survival. Due to the short prognosis following diagnosis it is notoriously difficult to run interventional therapeutic clinical trials in this patient population. Patients usually present with locally advanced and metastatic disease and as a consequence are often of poor performance status making clinical trial participation very problematic. If potential therapeutic targets could be identified in vivo it would potentially open up new therapeutic avenues whilst sparing some patients with the 'wrong' molecular profile futile treatment. This is a unique project within the setting of anaplastic thyroid cancer research.
Voice Outcomes Following Thyroidectomy
Thyroid CancerThyroid NoduleThis is an observational study of voice outcomes in participants following thyroidectomy or another head and neck surgery that does not involve risk to the larynx other than risks incurred due to intubation alone. These comparative (non-thyroidectomy) surgeries would not be expected to interfere with the primary nerves involved with voice production, so they would help to better understand the effect of intubation alone on voice outcomes.
AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making...
Thyroid NodulesThyroid CancerThere is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate when deciding the next step in management for a thyroid nodule. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer.