Klinische und genetische Studien bei familiärem nicht-medullärem Schilddrüsenkrebs
Background:
- Researchers are studying types of thyroid cancer that seem to cluster in families. Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer, but little is known about possible genes that may cause the cancer. More research is needed to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that it can be diagnosed and treated at an early stage.
Objectives:
- To evaluate the natural history of FNMTC.
- To determine the best screening strategy for FNMTC.
- To identify genes that may indicate susceptibility to FNMTC.
Eligibility:
- Individuals at least 7 years of age who have two first-degree relatives (e.g., parents, children, siblings) who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer.
Design:
- Participants will be evaluated by family history pedigree, physical examination, imaging (including possible neck ultrasound and radioactive iodine scans), and laboratory testing.
- Participants who agree to have blood or other biological samples collected will be asked to enroll in an additional study to provide the appropriate samples and tissues.
- After the initial study evaluation, participants who are not found to have a malignant thyroid tumor will be re-screened every year with non-invasive imaging studies. Participants who are found to have a malignant thyroid tumor will be informed of possible treatment options.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Detaillierte Beschreibung
Study Description:
This is a prospective cohort study of individuals with or at risk for non-medullary thyroid cancer. Individuals will be studied over time within the context of their families in order to quantify prospective risks of cancers in family members, to establish the natural history of FNMTC, define the spectrum of diseases within the families, to identify precursor states, to try to assess the contribution of genetic and environmental components of risk, and to develop effective screening strategies.
Objectives:
- To evaluate the natural history of familial non-medullary thyroid cancer (FNMTC).
- To determine the best screening strategy for FNMTC.
- To identify susceptibility gene(s) for FNMTC.
Endpoints:
Not applicable
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Joanna Klubo-Gwiezdzinska, M.D.
- Telefonnummer: (301) 496-5052
- E-Mail: joanna.klubo-gwiezdzinska@nih.gov
Studieren Sie die Kontaktsicherung
- Name: Padmasree Veeraraghavan, R.N.
- Telefonnummer: (301) 451-7710
- E-Mail: ncieobinquiry@mail.nih.gov
Studienorte
-
-
Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20892
- Rekrutierung
- 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
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
An individual with 2 first-degree relatives who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer (Note: as this is a familial study, subjects do not need to present with the disease) OR Any member of an affected family. (Note: for this study, an affected family is defined as a family having 2 or more 1st degree relatives with a documented diagnosis of FNMTC.)
Beschreibung
- INCLUSION CRITERIA:
Subjects will be selected for this protocol based on either a clinical diagnosis of non-medullary thyroid cancer and the presence of one family member with the disease or the presence of 2 living family members with this disease. Patient selection for this protocol will not be based on gender, race, or ethnic background.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults or minor (>= 7 years+), males and females.
- An unaffected individual with (Bullet) 2 first-degree relatives who have or have had nonmedullary thyroid cancer
OR
-An affected individual with documented diagnosis of non-medullary thyroid cancer and (Bullet) one living relative with documented non-medullary thyroid cancer (Note: as this is a familial study, subjects do not need to present with the disease)
OR
- Any member of an affected family. (Note: for this study, an affected family is defined as a family having 2 or more 1st degree relatives with a documented diagnosis of FNMTC.)
- Adults must be able to understand and the willingness to sign the informed consent document.
- Adults must be able to complete the family history questionnaire.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be not be allowed to enroll in this study:
-Subjects unwilling/unable to give informed consent.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Anzahl der Gruppen / Kohorten
Kohorten und Interventionen
Gruppe / KohorteGruppe / Kohorte |
|---|
|
1/ Cohort 1
Affected with non-medullary thyroid cancer |
|
2/ Cohort 2
Non-affected members of families with non-medullary thyroid cancer |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
To evaluate the natural history of FNMTC
Zeitfenster: end of study
|
Evaluation the natural history of FNMTC |
end of study
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Joanna Klubo-Gwiezdzinska, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Chen AY, Jemal A, Ward EM. Increasing incidence of differentiated thyroid cancer in the United States, 1988-2005. Cancer. 2009 Aug 15;115(16):3801-7. doi: 10.1002/cncr.24416.
- Vriens MR, Suh I, Moses W, Kebebew E. Clinical features and genetic predisposition to hereditary nonmedullary thyroid cancer. Thyroid. 2009 Dec;19(12):1343-9. doi: 10.1089/thy.2009.1607.
- Ito Y, Kakudo K, Hirokawa M, Fukushima M, Yabuta T, Tomoda C, Inoue H, Kihara M, Higashiyama T, Uruno T, Takamura Y, Miya A, Kobayashi K, Matsuzuka F, Miyauchi A. Biological behavior and prognosis of familial papillary thyroid carcinoma. Surgery. 2009 Jan;145(1):100-5. doi: 10.1016/j.surg.2008.08.004. Epub 2008 Sep 21.
- Klubo-Gwiezdzinska J, Yang L, Merkel R, Patel D, Nilubol N, Merino MJ, Skarulis M, Sadowski SM, Kebebew E. Results of Screening in Familial Non-Medullary Thyroid Cancer. Thyroid. 2017 Aug;27(8):1017-1024. doi: 10.1089/thy.2016.0668. Epub 2017 Jul 19.
- Chuki E, Behairy N, Auh S, Makarewicz A, Uttarkar Vikram CN, Kumari S, Veeraraghavan P, Cochran C, Gubbi S, Klubo-Gwiezdzinska J. Comparison of Progression-Free Survival in Familial Non-Medullary Thyroid Cancer and Sporadic Differentiated Thyroid Cancer Patients. Thyroid. 2025 Jun;35(6):642-651. doi: 10.1089/thy.2024.0588. Epub 2025 May 20.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 100102
- 10-DK-0102
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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