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Thyroid Cancer clinical trials

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NCT ID: NCT02347683 Completed - Thyroid Cancer Clinical Trials

Optimal Measurement of Thyroglobulin Measurement Following Thyroidectomy

Start date: January 1, 2015
Phase:
Study type: Observational

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.

NCT ID: NCT02244463 Completed - Thyroid Cancer Clinical Trials

A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer

Start date: July 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is a phase I/II study of MLN0128 in metastatic anaplastic thyroid cancer(ATC) and incurably poorly differentiated or radioidodine refractory differentiated thyroid cancer (DTC). Due to changes in the manufacturing process which resulted in increased absorption of MLN0128 from capsules, a run-in phase I prior to the phase II of the study was needed. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a treatment for any disease. MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells which may make the cancer more sensitive to inhibition by MLN0128. Given the activity with everolimus in RAI refractory thyroid cancer, subjects wth metastatic, incurable differentiated RAI refractory and poorly differentiated thyroid cancer were included.

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: NCT02223052 Completed - Breast Cancer Clinical Trials

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

Start date: October 27, 2014
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.

NCT ID: NCT02156362 Active, not recruiting - Thyroid Cancer Clinical Trials

Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)

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

It is generally estimated that 5 % of patients with thyroid cancer will develop distant metastases, and most of them had an advanced stage of the disease at presentation. Thirty per cent of them are resistant to radio iodine therapy and are called "refractory". Their long term survival is estimated to be less than 10 %. The objective of this study is to identify the factors associated with poor outcome in a cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and medullary thyroid carcinomas were excluded.

NCT ID: NCT02084732 Completed - Thyroid Cancer Clinical Trials

Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study

Start date: October 1, 2013
Phase: Phase 2
Study type: Interventional

Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010). Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system. The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy. Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells. VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival. Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies. Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms. Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.

NCT ID: NCT02018276 Completed - Thyroid Cancer Clinical Trials

Effect of Perioperative Intravenous Lidocaine Infusion and Magnesium Infusion on the Functional Recovery After General Anesthesia in the Patients Undergoing Thyroid Surgery

Start date: December 2013
Phase: N/A
Study type: Interventional

Studies have attempted to control pain and increase patients' recovery satisfaction following many kinds of operations by using as small an opioid analgesic dose as possible and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical stimuli. Lidocaine acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor. An intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control by reducing postoperative pain and opioid consumption. Another report showed that an intraoperative intravenous injection of lidocaine improved the quality of postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy patient. In addition, a review article on the effect of intraoperative intravenous injection of magnesium found it to be an effective analgesic that may be added to conventional opioid-based therapy because it generally reduces opioid consumption, decreases pain assessment for 24 hours after surgery, and lacks severe side effects in relation to magnesium administration. However, there has been insufficient research comparing the intraoperative intravenous injection of lidocaine or magnesium in terms of which is more helpful for general functional recovery and decreased postoperative pain. Recently, the scope of research on anesthesia has come to embrace postanesthetic recovery; to help patients return to daily life, the research trend is now shifting from the improvement or resolution of a specific symptom to the measurement of general recovery. Postoperative recovery is a complicated process related to such catamnestic factors as physiological end-points, the incidence of adverse events, and changes in psychological status. A widely used method to measure postoperative recovery is the Quality of Recovery 40 (QoR-40) survey. The QoR-40 includes a total of 40 questions that may be divided into five sub-categories: emotional state, physical comfort, psychological support, physical independence, and pain. The respondent answers each question on a 5-point scale, with one being worst and five being best. The QoR-40 takes 6.3 minutes on average to complete and is known to have good test-retest reliability, internal consistency, and split-half reliability. With respect to anesthetic recovery, the QoR-40 has been used in various studies to investigate how the surgery type, anesthesia method, administration of an additional drug, and gender affect anesthesia and surgery. The validity of the QoR-40 for research purposes has already been established. Therefore, in this study, we investigated the intraoperative intravenous injection of lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in the functional recovery of thyroidectomy patients after general anesthesia.

NCT ID: NCT02012699 Recruiting - Breast Cancer Clinical Trials

Integrated Cancer Repository for Cancer Research

iCaRe2
Start date: November 1, 2013
Phase:
Study type: Observational [Patient Registry]

The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

NCT ID: NCT02012686 Completed - Neck Pain Clinical Trials

The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after thyroidectomy.

NCT ID: NCT02012231 Terminated - Colorectal Cancer Clinical Trials

Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers.

Start date: February 2014
Phase: Phase 1
Study type: Interventional

The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension Cohorts (Phase IIa portion). The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with advanced BRAF-mutated cancers.