Clinical Trial: Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Brief Summary:

Background:

  • Endocrine neoplasms (tumors) are among the fastest growing tumors in incidence in the United States. Furthermore, it is often difficult to distinguish between benign or malignant tumors in cancers of the thyroid, parathyroid, adrenal gland, and pancreas. More research is needed to improve detection and treatment options for patients who develop these kinds of cancer.
  • Researchers are interested in studying the molecular changes that are involved in endocrine cancer development and growth. To collect a sample of tumor specimens and healthy tissue for further study, researchers are specifically looking for samples from patients who are scheduled for surgery or biopsy on endocrine tumors.

Objectives:

- To collect samples of precancerous, cancerous, and healthy tissue from individuals who are scheduled for surgery or biopsy of endocrine system tumors.

Eligibility:

- Individuals who have a tumor in or around their thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue, and are scheduled for surgery at the National Institutes of Health Clinical Center.

Design:

  • Participants in this study will provide blood and urine samples prior to surgery.
  • During the surgery or biopsy, pieces of the tumor or precancerous growth and pieces of normal tissue near to the tumor will be removed for ongoing and future research. The rest of the tumor or growth will be sent for analysis.
  • After surgery, p

    Detailed Summary:

    Background:

    • Endocrine neoplasms are among the fastest growing tumors in incidence in the United States. Between 1995 and 2005, the incidence of thyroid carcinoma has increased 98 percent.
    • Tumors of the thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among some of the most difficult tumors to clinically and histopathologically distinguish as benign or malignant.
    • Moreover, endocrine neoplasm provide an extremely important model for studying the important molecular changes that lead to carcinogenesis because of their diverse clinical behavior, even when having the same TNM stage and histologic features.
    • The Endocrine Surgery Section of the Surgery Branch, NCI has a focus on studying the molecular changes that are involved in Endocrine Cancer initiation and progression. In addition, this section has primary responsibility for providing endocrine surgery consultative services to the NIH. As such, our Section is uniquely positioned to acquire and perform important studies on endocrine tissue to help identify diagnostic and predictive markers, as well as, therapeutic targets that may have significant clinical ramifications. Some of the patients enrolled in this study may be on other protocols throughout the NIH, for which our Section is consulted in order to perform their operation.

    Objectives:

    Primary Objective:

    - To develop a genetic and epigenetic, metabolomic, and proteomic profile of endocrine neoplasm that will allow us to distinguish benign from malignant tumor for each of the endocrine histologies under study. This objective will drive the statistical en
    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome: To develop a genetic, epigenetic, metabolomic, and proteomic profile of endocrine neoplasm that will allow us to distinguish benign from malignant tumor for each of the endocrine histologies under study. [ Time Frame: ongoing ]

    Original Primary Outcome:

    Current Secondary Outcome:

    • To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression,epigenetic (methylation) changes, and metabolite and protein expression. [ Time Frame: ongoing ]
    • To obtain, when accessible, normal endocrine and other adjacent tissue for comparison with the neoplastic tissue including the comparison of genomic profiling data to determine the best approach for normalizing expression data. [ Time Frame: ongoing ]
    • To collect tissues from endocrine neoplasms arising in the thyroid, parathyroid, adrenal, pancreas, and extraadrenal neuroendocrine rests for future analysis and correlation with clinical outcome. [ Time Frame: ongoing ]


    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: October 30, 2009
    Date Started: September 22, 2009
    Date Completion:
    Last Updated: April 21, 2017
    Last Verified: December 2, 2016