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- Klinische proef NCT00001160
Studies over tumoren van de schildklier
Studies over schildklierknobbeltjes en schildklierkanker
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....
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Joanna Klubo-Gwiezdzinska, M.D.
- Telefoonnummer: (301) 496-5052
- E-mail: joanna.klubo-gwiezdzinska@nih.gov
Studie Contact Back-up
- Naam: Padmasree Veeraraghavan, R.N.
- Telefoonnummer: (301) 451-7710
- E-mail: padmasree.veeraraghavan@nih.gov
Studie Locaties
-
-
Maryland
-
Bethesda, Maryland, Verenigde Staten, 20892
- Werving
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Telefoonnummer: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.
Beschrijving
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_ONLY
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
thyroid cancer
Patients with thyroid cancer |
For evaluation risk/benefit evaluation |
|
thyroid nodules
Patients with thyroid nodules |
For evaluation risk/benefit evaluation |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluation of thyroid cancer
Tijdsspanne: 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
Tijdsspanne: As clinically indicated
|
blood draws, CT and other scans, physical exam. |
As clinically indicated
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Joanna Klubo-Gwiezdzinska, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publicaties en nuttige links
Algemene publicaties
- 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.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Endocriene klierneoplasmata
- Hoofd- en nekneoplasmata
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Carcinoom
- Schildklier Ziekten
- Adenocarcinoom, Papillair
- Schildklierkanker, Papillair
- Schildklier neoplasmata
- Adenocarcinoom, folliculair
- Schildklierkanker, Hurthle Cell
- Gallium GA 68 Dotatate
Andere studie-ID-nummers
- 770096
- 77-DK-0096
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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