Undersøgelser om tumorer i skjoldbruskkirtlen
Undersøgelser om Thyroid Nodules og Thyroid Cancer
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....
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Joanna Klubo-Gwiezdzinska, M.D.
- Telefonnummer: (301) 496-5052
- E-mail: joanna.klubo-gwiezdzinska@nih.gov
Undersøgelse Kontakt Backup
- Navn: Padmasree Veeraraghavan, R.N.
- Telefonnummer: (301) 451-7710
- E-mail: padmasree.veeraraghavan@nih.gov
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forenede Stater, 20892
- Rekruttering
- National Institutes of Health Clinical Center
-
Kontakt:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Telefonnummer: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.
Beskrivelse
- 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:
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
thyroid cancer
Patients with thyroid cancer |
For evaluation risk/benefit evaluation |
|
thyroid nodules
Patients with thyroid nodules |
For evaluation risk/benefit evaluation |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of thyroid cancer
Tidsramme: As clinically indicated
|
Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable). |
As clinically indicated
|
|
Evaluation of thyroid disorders
Tidsramme: As clinically indicated
|
blood draws, CT and other scans, physical exam. |
As clinically indicated
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Joanna Klubo-Gwiezdzinska, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i endokrine kirtler
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Karcinom
- Skjoldbruskkirtelsygdomme
- Adenocarcinom, papillært
- Kræft i skjoldbruskkirtlen, papillær
- Thyroidneoplasmer
- Adenocarcinom, follikulær
- Skjoldbruskkirtelkræft, Hurthle Cell
- gallium ga 68 dotatate
Andre undersøgelses-id-numre
- 770096
- 77-DK-0096
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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