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Thyroid Diseases clinical trials

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NCT ID: NCT02628067 Recruiting - Cervical Cancer Clinical Trials

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

Start date: December 18, 2015
Phase: Phase 2
Study type: Interventional

In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).

NCT ID: NCT02609685 Recruiting - Clinical trials for Papillary Thyroid Microcarcinoma

Active Surveillance of Papillary Thyroid Microcarcinoma

PMCAS
Start date: May 13, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.

NCT ID: NCT02602717 Recruiting - Thyroid Cancer Clinical Trials

The Evaluation of the Diagnostic Properties of Intra-operative In-situ Thyroglobin Levels of Cervical Lymph Nodes, in the Discrimination Between Benign and Malignant Lymph Nodes in Thyroid Cancer: a Prospective Multicentre Study.

Tgcyto
Start date: February 18, 2013
Phase: N/A
Study type: Interventional

Cytological examination of punctured lymph nodes is the gold standard for confirming metastatic lymph node spread of differentiated thyroid cancers. In order to increase the diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels of the aspirate could be included. Although this technique has been well proven, many uncertainties remain, especially with regards to a pathological cut-off value and its clinical utility when the thyroid is still intact. This uncertainty is mainly due to discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology, and their final histopathological analyses. To eliminate this uncertainty, cyto-punction will be performed intra-operatively after localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The thyroid gland might be present or absent (already operated) depending on the case. Finally, the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In order to determine whether the Tg values are appropriate in cases where the thyroid is intact, a control group has been included (First operation for thyroid cancer or benign pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection in patients for whom it is not indicated, only lymph nodes found along the incision path for neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed and excised.

NCT ID: NCT02462512 Recruiting - Thyroid Nodule Clinical Trials

Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

Elastography
Start date: April 2015
Phase: N/A
Study type: Observational

For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria for determining which nodule should be be aspirated are needed. Ultrasound elastography has been shown to be useful in the differential diagnosis of breast and prostate cancers. Ultrasound elastography also may discriminate malignant from benign nodule.

NCT ID: NCT02390128 Recruiting - Thyroid Function Clinical Trials

Mothers and Babies at Yorkhill Thyroid Health Cohort

MABY
Start date: January 2015
Phase: N/A
Study type: Observational

This is an observational study in pregnant mothers and their newborn babies. The rationale of the study is to examine early markers of the effects of iodine insufficiency during pregnancy on thyroid stimulating hormone (TSH) and thyroglobulin in mother and baby.

NCT ID: NCT02225509 Recruiting - Thyroid Cancer Clinical Trials

Clinical Validation of a Molecular Signature to Detect Cancer in Thyroid Nodules With Indeterminate Cytology

CITHY
Start date: October 2014
Phase: N/A
Study type: Interventional

1. 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. 2. 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. 3. 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.

NCT ID: NCT02203682 Recruiting - Autoimmune Diseases Clinical Trials

Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild Thyroid-Associated Ophthalmopathy (TAO).

NCT ID: NCT02088645 Recruiting - Clinical trials for Thyroid Cancer, Medullary

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

Lumed
Start date: April 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas. In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).

NCT ID: NCT01915485 Recruiting - Clinical trials for Medullary Thyroid Cancer

Radiolabeled Molecules for Medullary Thyroid Cancer

Start date: August 2013
Phase: Phase 4
Study type: Interventional

Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate which is a ligand to somatostatin receptors.

NCT ID: NCT01774279 Recruiting - Clinical trials for Anaplastic Thyroid Cancer

interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT)

iNATT
Start date: June 2013
Phase:
Study type: Observational [Patient Registry]

Anaplastic 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.