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Thyroid Neoplasms clinical trials

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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.

NCT ID: NCT01744769 Recruiting - Hypothyroidism Clinical Trials

Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer

Start date: July 2012
Phase: N/A
Study type: Observational

1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy. 2. Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters. 3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.

NCT ID: NCT01739634 Recruiting - Diarrhea Clinical Trials

The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.

NCT ID: NCT01704586 Recruiting - Clinical trials for Differentiated Thyroid Carcinoma

I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer

CLERAD-PROBE
Start date: May 2015
Phase: N/A
Study type: Interventional

Thyroid nodules are a common clinical problem. Epidemiologic studies have shown the prevalence of palpable thyroid nodules to be approximately 5% in women and 1% in men living in iodine-sufficient parts of the world and up to 30% in iodine deficient regions, such as Germany. The clinical importance of thyroid nodules rests with the need to exclude thyroid cancer which occurs in 5-15%. Differentiated thyroid cancer (DTC), which includes papillary and follicular cancer, comprises the vast majority (90%) of all thyroid cancers. In Germany, approximately 7,000 new cases will be diagnosed in 2011. The yearly incidence has increased from 3.6 per 100,000 in 1973 to 8.7 per 100,000 in 2002, and this trend appears to be continuing. Recurrence-free survival is generally excellent and depends on the risk group. The role of postoperative remnant radioiodine ablation (RRIA) as the most serious question regarding the initial management of DTC still needs to be resolved even after decades of radioiodine use. American Thyroid Association directions for future research addressing these questions include: - Better understanding of the long-term risks of radioiodine use; - Improved risk stratification; Randomized controlled trials are still missing in which RRIA has proven its worth as a safe and very effective treatment that results in an improved life expectancy and a reduced recurrence rate. Many observational studies lack sufficiently high evidence. Evidence grade is rated mainly on "expert level", based on non-randomized retrospective observation studies. Although RRIA in Europe is established as adjuvant standard treatment for all patients with DTC, except those with stage T1a, it remains to be shown throughout if it is beneficial for low risk and medium risk patients without metastases (M0), also known as stage I patients according to UICC/AJCC classification, accounting for 40-90% of all patients. Blood doses due to cumulative radioiodine therapy may well exceed 2 Gy, and RRIA induces an average blood dose of 0.28 Gy to the entire body. Risks as estimated from that dose are not insignificant. The question is whether or not the condition after remnant ablation justifies such an increased risk of a secondary malignancy. The probability of causation for a pharyngeal or breast tumour can well exceed the margin of a 50% after being exposed to RRIA or consecutive I-131 diagnostic imaging to explore measureable Tg levels. Even though radioiodine therapy can benefit some patients with advanced thyroid carcinoma, it is still unknown whether the risks of RRIA outweigh any discernable benefit. Undoubtedly, quality of life may be affected by adjuvant use of I-131. Study Hypothesis: The I-124 study arm may have considerable benefits for the patient included in the study. These include - enhanced tumour and risk stratification, - avoidance of unnecessary I-131 exposure in 30-89 percent of patients who were classified with "low risk" tumour (MACIS or AMES scoring) or "stage I disease" (UICC-AJCC TNM staging system), and, - improved quality of life at the same or better morbidity and mortality rates in the I-124 arm. Environmental and hospital staff related benefits include prevention or saving of I-131 exposure. This study is designed to compare effectiveness of treatments following and evaluating guideline recommendations in two assignment arms.

NCT ID: NCT01700699 Recruiting - Clinical trials for Differentiated Thyroid Cancer

Impact of BRAFV600E Intratumor Heterogeneity in Thyroid Cancer Treated With Tyrosine Kinase Inhibitors

Start date: October 2012
Phase: N/A
Study type: Observational

- Background: BRAFV600E is the most frequent oncogene in differentiated thyroid cancer (DTC) occurring in about 50% of cases. Clinical trials with tyrosine kinase inhibitors (TKI) with specific activity against BRAF in metastatic radioiodine-resistant DTC (MRR-DTC) are ongoing. Very recently it has been demonstrated that DTC often consists of a mixture of tumor cells with wild-type and mutant BRAF. The subclonal occurrence of BRAFV600E in MRR-DTC could disable the therapy with BRAF targeted TKI and be responsible of the frequent defeats of this treatment. A therapeutic strategy based upon BRAF inhibitors in tumors bearing subclonal BRAFV600E could be initially successful hitting the tumor cells expressing the oncogene, and after the initial tumor growth arrest and/or shrinkage, the oncogene negative cells insensitive or less sensitive to the treatment, could restart the growth of the tumor causing the progression of the disease and the escape from the clinical response. - Aims: To determine the impact of subclonal BRAFV600E on the efficacy of BRAF inhibitors in the treatment of MRR-DTC. - Study design: Primary tumor tissues will be analyzed for the presence of BRAFV600E by pyrosequencing or other quantitative assay. If available, synchronous metastases and post-therapy metachronous metastases will be analyzed as well. The clinical response will be determined according to RECIST, and the association with the percentage of BRAFV600E alleles will be evaluated. Attention will be paid to the possible difference of BRAFwild-type/BRAFV600E ratio between primary tumors and synchronous metastases, primary tumors and post-therapy metachronous metastases, and between responsive and resistant synchronous tumor lesions.

NCT ID: NCT01668238 Recruiting - Breast Tumor Clinical Trials

Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry

Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of this stage of study is to establish discriminant among healthy tissue, benign and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.

NCT ID: NCT01660984 Recruiting - Clinical trials for Medullary Thyroid Cancer

Natural History Study of Children and Adults With Medullary Thyroid Cancer

Start date: July 30, 2012
Phase:
Study type: Observational

Background: - Medullary thyroid cancer (MTC) is a rare cancer of the thyroid gland. In children and adults, it is often part of a condition called Multiple Endocrine Neoplasia 2 (MEN2). MEN2 is usually caused by a genetic mutation, and it can cause a number of problems in addition to MTC. These problems include adrenal gland tumors, hormone changes, and problems with the bones and other organs. Not much is known about how MTC develops over time, especially in people with MEN2. Researchers want to study MTC in children and adults and see how it affects their growth and development. Objectives: - To study how medullary thyroid cancer affects children and adults over time. Eligibility: - Children and adults who have medullary thyroid cancer. Design: - Participants will be screened with a brief physical exam and medical history. Blood and tissue samples will be collected to see whether participants have the MEN2 genetic mutation. - Treatment will not be provided as part of this study. However, participants will be receiving standard care for MTC. They may be eligible for other clinical trials at the National Institutes of Health. - Participants will have regular study visits every 6 to 12 months to evaluate their MTC and any treatment. Blood tests, imaging studies, and other tests may be performed as needed to monitor the disease. - Participants and their parents/guardians will also complete questionnaires about their health and emotions during the study.

NCT ID: NCT01512212 Recruiting - Thyroid Cancer Clinical Trials

New Thyroid Fine Needle Aspiration Biopsy Apparatus

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

Evaluation of the effectivity of the new thyroid fine needle aspiration biopsy (FNAB) apparatus of which patented from Turkish Patent Institute.

NCT ID: NCT01471288 Recruiting - Clinical trials for Thyroid Cancer Patients

Effect of Carum Carvi on Thyroid Hormones and TSH Level

Start date: May 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin. TSH level returned to normal after discontinuation of the Carum carvi. This observation led to a pilot study for evaluation of the effect of carum carvi on thyroid function.

NCT ID: NCT01417442 Recruiting - Clinical trials for Papillary Thyroid Carcinoma

BRAF V600E Mutations In Papillary Thyroid Carcinoma

Start date: July 2011
Phase: Phase 0
Study type: Interventional

The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.