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Идёт набор NCT00001160

Studies on Tumors of the Thyroid

Наблюдательное Hurthle Cell Thyroid Cancer Tall Cell Variant Thyroid Cancer Follicular Thyroid Cancer Thyroid Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 68-Gallium Dotatate.
Кому может быть актуально
Состояния в реестре: Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer, Follicular Thyroid Cancer, Thyroid Cancer. Базовые параметры: 6 мес. — 98 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Studies on Thyroid Nodules and Thyroid Cancer

Обзор

Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer. The main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.

Подробное описание

The purpose of this study is to gain knowledge and experience in the diagnosis and therapy of thyroid cancer using established best standard of care and new techniques and approaches as they are developed. Study subjects will include adults and children with thyroid nodules requiring diagnostic imaging and fine needle aspiration biopsy, surgery, radioiodine scanning or therapy, appropriate follow up, consisting of tumor markers monitoring and anatomical and functional imaging. The limitations and significance of serum thyroglobulin (Tg) measurement for diagnosing tumor recurrence will be assessed. The study will permit a continued evaluation of the risk/benefit ratio of already established methods of administering radioiodine therapy, including the impact of pre-treatment dosimetric calculations, individualizing treatment with radioiodine. Under this protocol, samples of benign nodules and cancer tissue specimens for research studies will be collected. Data and samples collected during routine clinical care will be used to address research questions utilizing a number of approaches including microscopy, immunohistochemistry, proteomics and molecular analysis. All research studies will relate to the diagnosis, natural history and therapy of thyroid tumors, regulation of thyroid function, and the effects of thyroid function on the body. Blood and urine specimens will be collected for research studies in both the hypothyroid and euthyroid state.

Вмешательства

  • Препарат 68-Gallium Dotatate
    For evaluation risk/benefit evaluation

Первичные конечные точки

  • Evaluation of thyroid cancer [Срок оценки: As clinically indicated]
  • Evaluation of thyroid disorders [Срок оценки: As clinically indicated]

Критерии участия

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Male or female, adults or children >= 6 months+.
  • Patients with known or suspected thyroid nodules and/or thyroid cancer.
  • At risk family members of patients who have a genetic susceptibility to developing thyroid cancer.

Критерии исключения

An individual who meets any of the following criteria will be excluded from participation in this study:

1\. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • National Institutes of Health Clinical Center — Bethesda

Публикации

  • Klubo-Gwiezdzinska J, Wartofsky L. The Role of Molecular Diagnostics in the Management of Indeterminate Thyroid Nodules. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3507-3510. doi: 10.1210/jc.2018-01081. PMID 30032182
  • Thakur S, Tobey A, Daley B, Auh S, Walter M, Patel D, Nilubol N, Kebebew E, Patel A, Jensen K, Vasko V, Klubo-Gwiezdzinska J. Limited Utility of Circulating Cell-Free DNA Integrity as a Diagnostic Tool for Differentiating Between Malignant and Benign Thyroid Nodules With Indeterminate Cytology (Bethesda Category III). Front Oncol. 2019 Sep 18;9:905. doi: 10.3389/fonc.2019.00905. eCollection 2019. PMID 31620364

Идентификаторы

NCT: NCT00001160 · 770096 · 77-DK-0096

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗