Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date February 11, 2021
Actual Study Start Date June 1, 1977
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: August 27, 2020)
  • Evaluation of thyroid cancer [ Time Frame: As clinically indicated ]
    Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).
  • Evaluation of thyroid disorders [ Time Frame: As clinically indicated ]
    blood draws, CT and other scans, physical exam.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studies on Tumors of the Thyroid
Official Title Studies on Thyroid Nodules and Thyroid Cancer
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.
Condition
  • Hurthle Cell Thyroid Cancer
  • Tall Cell Variant Thyroid Cancer
  • Follicular Thyroid Cancer
  • Thyroid Cancer
  • Papillary Thyroid Cancer
Intervention Not Provided
Study Groups/Cohorts
  • thyroid cancer
    Patients with thyroid cancer
  • thyroid nodules
    Patients with thyroid nodules
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 27, 2020)
2500
Original Enrollment
 (submitted: June 23, 2005)
999
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001160
Other Study ID Numbers 770096
77-DK-0096
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators Not Provided
Investigators
Principal Investigator: Joanna Klubo-Gwiezdzinska, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 9, 2021