Studies on Tumors of the Thyroid

  • STATUS
    Recruiting
  • End date
    Dec 31, 2040
  • participants needed
    2500
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 8 August 2022
cancer
thyroid nodule

Summary

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....

Description

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.

Details
Condition Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer, Follicular Thyroid Cancer, Thyroid Cancer, Papillary Thyroid Cancer
Treatment MRI scan, CT Scan, 68-Gallium-DOTATATE, 18-FDG PET/CT scan
Clinical Study IdentifierNCT00001160
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on8 August 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation
in this study
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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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