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Studies on Tumors of the Thyroid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001160
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
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Brief 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.


Condition or disease
Hurthle Cell Thyroid Cancer Tall Cell Variant Thyroid Cancer Follicular Thyroid Cancer Thyroid Cancer Papillary Thyroid Cancer

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Studies on Thyroid Nodules and Thyroid Cancer
Actual Study Start Date : June 1, 1977

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort
thyroid cancer
Patients with thyroid cancer
thyroid nodules
Patients with thyroid nodules


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of thyroid cancer [ Time Frame: As clinically indicated ]
    Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).

  2. Evaluation of thyroid disorders [ Time Frame: As clinically indicated ]
    blood draws, CT and other scans, physical exam.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.
Criteria
  • INCLUSION CRITERIA:

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

  1. Male or female, adults or children >= 6 months+.
  2. Patients with known or suspected thyroid nodules and/or thyroid cancer.
  3. 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:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001160


Contacts
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Contact: Padmasree Veeraraghavan, N.P. (301) 451-7710 padmasree.veeraraghavan@nih.gov
Contact: Joanna Klubo-Gwiezdzinska, M.D. (301) 496-5052 joanna.klubo-gwiezdzinska@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Joanna Klubo-Gwiezdzinska, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Additional Information:

Publications:

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00001160    
Other Study ID Numbers: 770096
77-DK-0096
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 10, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .Subject level data will be shared upon request after appropriate collaboration agreements are in place.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Thyroid Fine Needle Biopsy
Radioiodine
Dosimetry
Natural History
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Adenocarcinoma, Follicular
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
 Neoplasms
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type