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Thyroid Neoplasms clinical trials

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NCT ID: NCT06095362 Enrolling by invitation - Surgery Clinical Trials

Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW

TARGET-beva
Start date: November 29, 2021
Phase: Phase 1
Study type: Interventional

Background: Papillary thyroid cancer (PTC) patients often develop central lymph node metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent local recurrence, and opponents objecting to the hypoparathyroidism and nerve damage risk. Currently, no diagnostic tool exists to identify patients who would benefit from a PCLND. Molecular Fluorescence Guided Surgery (MFGS) is a potential solution that uses fluorescent tracers to detect cancerous tissue. This study aims to investigate whether the administration of a GMP-produced near infrared (NIR) tracer, bevacizumab-IRDye800CW, targeting VEGF-A, can enable intraoperative selection of PTC/FTC/HTC patients for CLND. Objective: The primary objective of the study is to determine the optimal dose of bevacizumab-IRDye800CW for an adequate tumor-to-background ratio (TBR) in PTC/FTC/HTC lymph node metastases. The secondary objectives are to evaluate the feasibility of MFGS for PTC/FTC/HTC and nodal metastasis assessment, to correlate and validate fluorescence signals detected in vivo with ex vivo histopathology and immunohistochemistry, to evaluate the distribution of bevacizumab-IRDye800CW on a microscopic level, and to quantify the sensitivity and specificity of bevacizumab-IRDye800CW for PTC/FTC/HTC and nodal metastasis. Study Design: The TARGET-BEVA study is a non-randomized, non-blinded, prospective, single-center phase I feasibility study for patients with confirmed PTC/FTC/HTC, for which the best TBR dosage group in PTC/FTC/HTC nodal metastasis will be determined. The study will initiate with a 3 x 3 scheme: 4,5 mg, 10 mg, and 25 mg, with three patients confirmed with lymph node metastasis in each group. Dosages will be based on previous studies, with the primary objective being the detection of lymph node metastasis. After the first 9 patients, an interim analysis will be performed, after which the best dosage group will be expanded with another 7 patients. Conclusion: The study aims to identify a novel diagnostic tool that can aid clinicians in selecting patients for PCLND, enabling a reduction in overtreatment, morbidity, and costs while maintaining effectiveness with a lower recurrence rate and improved quality of life.

NCT ID: NCT04904159 Enrolling by invitation - Thyroid Cancer Clinical Trials

Scoring System for Thyroid Gland Pathologies

Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

Although anamnesis and physical examination remain the place in the evaluation of patients today; laboratory values, imaging methods and pathology results have come to the fore in the decision-making of surgery for patients. As a result of all other criteria, a follow-up decision can be changed in a patient with a single fine needle aspiration biopsy result, or despite all the examinations the investigators have, a clear result cannot be achieved, and patient management may be disrupted. A holistic approach to thyroid gland pathologies is planned thanks to the scoring system that will be created in this study.

NCT ID: NCT04411290 Enrolling by invitation - Thyroid Nodule Clinical Trials

Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases

Start date: May 15, 2020
Phase:
Study type: Observational

In the last decades, thyroid cancer incidence has continuously increased all over the world, almost exclusively due to a sharp rise in the incidence of the papillary histologic subtype, which has the highest incidence of multifocality. Furthermore, Black Sea and Eastern European regions are both endemic and known to have been under the influence of Chernobyl nuclear explosion. Although overscreening might have a role in certain parts of the world, the predictors of malignancy such as family history, genetical disorders, previous radiation exposure, low iodine intake, diabetes and obesity, should also be taken into consideration in determining the extent of surgery.

NCT ID: NCT03794375 Enrolling by invitation - Clinical trials for Differentiated Thyroid Cancer

Primary Care Transfer for Thyroid Cancer Patients

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Introduction: Differentiated thyroid cancer (DTC) is the most common endocrine malignancy. It presents low recurrence rates (2-5%) and the consensus of DTC recommends long-term follow-up, without a definition of maximum follow-up time. The use of Telehealth is a strategy that aims to optimize the transition of care for patients from tertiary care to primary health care, helping to follow up these patients. Objective: To evaluate the impact of the care transition between specialized care and primary health care of patients with DTC using telemedicine solutions. Design / Patients: Randomized clinical trial. Patients with DTC with excellent response (without evidence of disease) after initial treatment. Interventions / Outcomes: Patients will be randomized to follow-up in face-to-face consultations in tertiary care or transfer of care to primary care with support from the Telehealth Center of Rio Grande do Sul. After 18 months, all patients will be evaluated, the primary outcome being DTC recurrence rate. Outcomes related to quality of life and use of the health system will also be evaluated. Both follow-up strategies are expected to be equivalent, making it possible to optimize the use of the health system.

NCT ID: NCT01579344 Enrolling by invitation - Clinical trials for Lacrimal Apparatus Disease

Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Start date: January 2012
Phase: N/A
Study type: Interventional

The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature. Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients. It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.

NCT ID: NCT01511393 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)

Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new adult cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.

NCT ID: NCT00822289 Enrolling by invitation - Hyperthyroidism Clinical Trials

The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication

Start date: February 2009
Phase: N/A
Study type: Observational

Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori. Also to test the hypothesis that CagA virulent strains of H.pylori are more common in patients with thyroid cancer than with other thyroid diseases.

NCT ID: NCT00297297 Enrolling by invitation - Thyroid Nodules Clinical Trials

Improved Preoperative Selection of Cold Thyroid Nodules

Start date: December 2008
Phase: Phase 3
Study type: Observational

Molecular gene profiling of fine-needle aspiration samples in addition to fine-needle aspiration cytology can improve the selection of patients with benign versus malignant thyroid nodules with improved sensitivity.