Active clinical trials for "Thyroid Neoplasms"

Recently published European guidance recommends the evaluation of the radiation dose to the bone marrow in patients undergoing radioiodine therapy for thyroid cancer. The methods described in these guidelines require serial blood samples to be taken from the patient, followed by a sophisticated analysis to determine the radiation dose. However, radiation risk assessments carried out locally have indicated that a relatively high radiation exposure will be received by the operator taking the blood samples, which may prohibit this procedure being carried out routinely. The radiation dose to the operator will be lowered if the duration of the blood sampling procedure were reduced. The investigators hypothesize that the use of a lancet and pipette to collect blood from the finger tip will greatly reduce the time spent in proximity to the patient, significantly reducing the operator exposure and allowing this procedure to be performed routinely. The proposed method is also less invasive for the patient compared to the intravenous sampling recommended in the guidelines. A proof-of-principal pilot project using radioiodine diluted to the expected concentration in blood has indicated that using very small volumes of blood (such as from a lancet) does not compromise the accuracy of the dosimetry measurement when compared to large-volume standard blood samples. The primary aim of this study is to investigate whether sampling a small volume of blood using a lancet and pipette can replace standard intravenous blood samples for bone marrow dosimetry in patients undergoing radioiodine treatment for thyroid cancer. Statistical tests will determine whether there is a significant difference between the doses calculated using each blood sampling method. In addition, the investigators will measure the radiation exposure received by the operator during each procedure using Electronic Portable Dosimeters. The results of these measurements will be used to quantify the reduction in operator radiation exposure afforded by the new technique.

The optimal timing to measure thyroglobulin(Tg) after thyroidectomy is unknown in patients with thyroid cancer. The ATA and NCCN guidelines are not specific on optimal timing of Tg levels in post-op state and suggest anywhere between 2-12 weeks. Hypothesis - Post -op Tg nadirs at 6-8 weeks . Primary Objective -Determine optimal timing of post thyroidectomy Tg nadir, so to determine the most accurate time to check post operatively. Secondary Outcome - Determine factors that will affect Tg levels post operatively. All adults age 19 and above already planning to undergo near total /total thyroidectomy for reasons unrelated to the study. Measure Tg , Tg Ab and TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, and 3 month in patients with pathology confirmed benign disease. Measure Tg , Tg Ab , TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, 3 month, 6 month, and 12 month in patients with thyroid cancer.

Principal objective: The primary objective of this study is to validate the diagnostic performance of a Dx15 molecular test based on molecular transcriptomic signatures previously identified in distincts cohorts of samples to determine the malignant or benign profile of a thyroid nodule with indeterminate cytological analysis. The target population includes categories III [Follicular lesion of undetermined significance or Atypia of undetermined significance (FLUS/AUS)] and IV [Follicular neoplasm / Suspicious for follicular neoplasm (FN/SFN)] of the Bethesda classification. The expected target performance of the Dx15 molecular test in this target population is 95% for specificity with a lower limit of the 95% confidence interval of 87%, and 75% for sensitivity. Secondary objectives: To assess the performance of the Dx15 test in samples collected during the study by fine-needle aspiration (FNA) in each and in all of the indeterminate Bethesda classification categories (categories III, IV and V: suspected malignancy) To assess the performance of the TI-RADS ultrasonography score for diagnosing thyroid cancer in patients presenting with a thyroid nodule and having available cytological analysis results. To check the potential of performance of the molecular signature as well as of its combination with other tests by applying it in a blind manner to samples collected from patients presenting with thyroid nodules and whose aspiration biopsy result is benign (Bethesda category II), malignant (Bethesda category VI) or non-diagnostic (Bethesda category I) To assess the performance of mutation tests (isolated mutations, chromosomal rearrangements) for diagnosing thyroid cancer in patients presenting with a thyroid nodule and with available cytological results. To estimate the performance of the combination of the Dx15 test result and other diagnostic tools such as mutation tests and/or the TI-RADS score to diagnose thyroid cancer in patients presenting with a thyroid nodule and having an indeterminate cytology result (especially AUS/FLUS and FN/SFN). The combination of Dx15 diagnostic test results with other study parameters will also be considered in order to establish the option of an algorithmic approach for the diagnosis of thyroid cancer. To compare the results of cytological and histological analyses obtained in the centres and by centralised reading and assessment of the impact of its results on the other study analyses and parameters. Additional analyses deemed relevant on the basis of various parameters and data collected during the study. Objective of exploratory research: The use of all or part of the FNA samples for the purpose of research as part of thyroid cancers, especially with the objective of optimising or identifying additional molecular signatures.

Patients undergoing thyroidectomy will be divided into three groups (30 cm H2O Group I, 40 cm H2O Group II, 50 cmH2O Group III). At the end of the operation patients will be applied peak airway pressure manually according to involved groups.The time until the first hemorrhage is seen in each group or if not seen pressure will be applied for 30 seconds and then will be ended.We will record the blood pressure, spO2, HR, the first ETCO2 after the procedure, postoperative haemorrhage that required surgery, and postoperative hematomas during peak airway pressure increase during the operation in all patients. The 1st hour blood pressure, nausea-vomiting score and pain score (NRS) will be recorded in the postoperative recovery unit. The primary end point of the study is intraoperative bleeding detected, and the secondary end point is postoperative bleeding.

Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. Much progress has been made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. Besides the improvement of diagnosis, TC increasing incidence emphasize that other important factors such as the environment play an important role in disease pathogenesis. While microbiota as an environment factor to some cancers accept widespread attention, if microbiota also as a risk factor for TC, it is worthy to be considered.

Diagnosis and treatment of differentiated thyroid carcinomas cause anxiety and depression. Additionally, these patients suffer hormonal alterations, associated with psychological symptoms (changes in mood, emotional instability, memory loss, etc.). This study aims to evaluate the effectiveness of a psycho-oncological intervention based on Counselling to reduce anxiety and depression related with the treatment in patients with differentiated thyroid carcinomas.

Aim/Introduction: The treatment of differentiated thyroid cancer includes generally a total thyroidectomy, followed by a radioiodine (131I)-therapy. Due to their ability to concentrate iodine, the salivary glands may present inflammation after administration of 131I, which may be symptomatic, may lead to longer-term chronic abnormalities, resulting in alterations in patients' nutrition and quality of life. The incidence of salivary dysfunctions after 131I-therapy varies considerably between studies due to methodological limitations. Also, the occurrence of these dysfunctions may be linked to increased uptake and/or retention of 131I in the salivary glands and/or individual radiosensitivity. However, no clinical or genetic factors have been identified to date to define patients at risk, allowing the delivered activity to be adapted to the expected risk of salivary dysfunctions. The aims of this study are to estimate the incidence of salivary dysfunctions after 131I-therapy, to characterize patients at risk of developing post-treatment dysfunctions using clinical, biomolecular and biochemical factors, and to validate a dosimetric method to calculate the dose received at the salivary gland level in order to analyse the dose response relationship between exposure of salivary glands to 131I and salivary dysfunctions. Materials and Methods: This prospective cohort aims to include 120 patients, candidates for a 131I-therapy in the context of their differentiated thyroid cancer, treated in the Nuclear Medicine department of the Pitié-Salpêtrière hospital (40 and 80 patients in a 1.1GBq and a 3.7GBq dose groups respectively). The follow-up is based on 3 scheduled visits: at inclusion (immediately before 131I therapy), 6months and 18months after treatment. For each visit, questionnaires on salivary disorders (validated French tool), quality of life (HAD-scale, MOS-SF-36), and nutritional status are administered. At inclusion and at T6, saliva samples and individual measurement of the salivary flow, without and with salivary glands stimulation, are performed. External thermoluminescent dosimeters are placed opposite the salivary glands and at the sternal fork on the treatment's day before radioiodine administration and removed 5days after treatment. From dosimeters, a reconstitution of the dose received at the salivary glands will be established using physical and computational phantoms. Genetic and epigenetic analyses will be performed to find biomarkers of predisposition to develop salivary disorders after 131I-therapy. Expected results Inclusion of patients started in September 2020 and are still ongoing. Statistical analyses will study the links between salivary dysfunctions and the 131I dose received by the salivary glands, taking into account associated factors. In addition, impacts on the patients' quality of life will be analysed.

Primary Objectives To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B). To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups. To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS). To compare the length of hospital stay between the two groups of patients.

The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT. Association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.

Most patients with differentiated thyroid carcinoma (DTC) are treated with therapeutic doses of radioiodine (131I) after initial surgery (total or near total thyroidectomy), aimed to destroy microscopic residual normal or tumoral thyroid cells and to facilitate the early detection of tumor recurrence based on serum thyroglobulin (Tg) measurement and 131I whole body scan (WBS) (1-5). Recently, preparation of patients for thyroid ablation with rhTSH and 3700 MBq of 131I on l-thyroxine (l-T4) therapy has been approved in Europe by the European Medicines Agency (EMEA) as an alternative to thyroid hormone withdrawal (6), after a randomized, controlled, multicenter study demonstrated that both methods of preparation are equally effective (with 100% rate of successful ablation) and that patients prepared with rhTSH received lower total body irradiation and experienced a better quality of life compared to those rendered hypothyroid (7). The present study was aimed to compare the efficacy of fixed activities of 1850 MBq versus 3700 MBq of 131I for post surgical thyroid ablation in DTC patients prepared with rhTSH (TSHα, Thyrogen®, Genzyme Therapeutics, Cambridge, MA) on l-T4 therapy.