- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00001160
갑상선 종양에 관한 연구
갑상선결절과 갑상선암에 관한 연구
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....
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Joanna Klubo-Gwiezdzinska, M.D.
- 전화번호: (301) 496-5052
- 이메일: joanna.klubo-gwiezdzinska@nih.gov
연구 연락처 백업
- 이름: Padmasree Veeraraghavan, R.N.
- 전화번호: (301) 451-7710
- 이메일: padmasree.veeraraghavan@nih.gov
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- 모병
- National Institutes of Health Clinical Center
-
연락하다:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- 전화번호: TTY dial 711 800-411-1222
- 이메일: ccopr@nih.gov
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
thyroid cancer
Patients with thyroid cancer |
For evaluation risk/benefit evaluation |
|
thyroid nodules
Patients with thyroid nodules |
For evaluation risk/benefit evaluation |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluation of thyroid cancer
기간: 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
기간: As clinically indicated
|
blood draws, CT and other scans, physical exam. |
As clinically indicated
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Joanna Klubo-Gwiezdzinska, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 770096
- 77-DK-0096
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Subject level data will be shared upon request after appropriate collaboration agreements are in place.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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