Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples
研究概览
简要总结
Background:
- Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are no tests that can accurately tell which adrenal tumors are cancerous and which are not. The only way to tell is to remove the tumor with surgery and then examine it. Researchers have been using new methods to study samples of adrenal tissue. These methods may help identify whether the cells are or may become cancerous without an operation. This information will help doctors determine which tumors will need to be removed.
Objectives:
- To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells.
Eligibility:
- Individuals at least 18 years of age who have an adrenal tumor that may or may not be cancerous.
Design:
- Participants will be screened with a physical examination, medical history, blood and urine tests, and imaging studies.
- Participants will be examined to determine whether they have a specific type of adrenal tumor
(pheochromocytoma).
- Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for study.
- Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Tissue will be collected for study.
- Researchers will examine the collected tissue. They will try to determine whether the cells are cancerous or may become cancerous.
- Participants will be asked to return to the National Institutes of Health Clinical Center every year for about 5 years. During these visits they will have imaging studies, lab tests, and a physical examination.
详细描述
Background:
- Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies.
- The majority of adrenal incidentalomas are cortical adenoma.
- Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to exclude a cancer diagnosis.
- There are no reliable clinical, radiographic or laboratory studies that accurately distinguish between localized benign and malignant adrenal neoplasm.
- This protocol is designed to determine the feasibility and accuracy of using novel molecular markers of malignant adrenal neoplasm in fine needle aspiration (FNA) biopsy and surgically resected samples.
Objectives:
-
Primary Objectives:
-
To evaluate the feasibility of molecular testing in adrenal neoplasm FNA biopsy samples.
-
To determine the accuracy of novel diagnostic molecular markers in clinical adrenal FNA biopsy and surgically resected samples.
-
Secondary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples
时间窗: 5 years
Feasibility of molecular testing in adrenal neoplasm fine needle aspiration (FNA) samples was determined by immunohistochemistry. Ribonucleic acid and deoxyribonucleic acid was extracted from fine needle aspiration and tumor tissue samples to differentiate between normal and abnormal tissue.
Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples
时间窗: 5 years
Tumor tissue obtained via FNA and surgical resection were to be analyzed for molecular markers to help determine if cells were cancerous or may become cancerous.
次要结局
- To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma(5 years)
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)(Date treatment consent signed to date off study, approximately 6 years and 58 days)
研究者
Naris Nilubol, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)