Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

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Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Study Purpose

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, participants will receive routine care until discharge, and doctors will discuss possible treatment options.

If there is an appropriate NIH protocol, participants may choose to be treated at the NIH.

- After discharge, participants will return to the clinic for a routine postoperative check about 6 weeks following the operation, and then may be followed yearly at the Clinical Center or by phone.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	4 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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INCLUSION CRITERIA:
- Patients who have an endocrine neoplasm based on radiographic and biochemical testing, or histologically/cytologically proven lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine nests, paragangliomas, neuroblastomas, gastrointestinal.

track and pancreas or patients with a described pre or potentially malignant condition that requires surgery or biopsy as a part of the standard of care treatment and/or follow up.

- Patients referred to the Endocrine Consult Service on other protocol for surgical evaluation of endocrine disorders based on radiographic and biochemical testing, or histologically/cytologically proven lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine nests, paragangliomas, neuroblastomas and pancreas.

- Patients must have an ECOG performance score of 0-2.

- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.

- Patients undergoing treatment for their neoplasm may be eligible.

- Patients must be planning to undergo surgery or biopsy as part of their treatment plan.

Note: Patients will not be enrolled exclusively for the procurement of tissue samples.

- Age is greater than or equal to 4 years of age.

Exclusion Criteria:

None

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01005654
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Naris Nilubol, M.D.
Principal Investigator Affiliation	National Cancer Institute (NCI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Endocrine Tumors, Thyroid Neoplasms, Parathyroid Neoplasms, Adrenal Neoplasm, Neuroblastoma
Study Website:	View Trial Website

Additional Details

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 gastrointestinal-pancreatic neuroendocrine tumors are among some of the most difficult tumors to clinically and histopathological distinguish as benign or malignant. Moreover, endocrine neoplasms 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 Surgical Oncology Program (formerly known as Endocrine Oncology 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, we are uniquely positioned to acquire and perform important studies to help identify diagnostic and predictive markers as well as therapeutic targets that may have significant clinical ramifications. Objectives: 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. This objective will drive the statistical endpoints of the study. Eligibility: Patients with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven, endocrine neoplasms, including lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine nests, paragangliomas, neuroblastomas, pancreas and gastrointestinal tract. Or patients with a described pre or potentially malignant condition that requires surgery or biopsy as a part of the standard of care treatment and/or follow up. Patients must have an ECOG performance score of 0-2. Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery. Design: A tissue acquisition trial in which tissues will be obtained at the time of surgical operation for the removal of neoplasms of the thyroid, parathyroid, adrenal, pancreas, paragangliomas and/or extra adrenal nests of neuroendocrine tissue, and gastrointestinal neuroendocrine tumors. At the time of surgical operation, blood samples will be obtained from the operative field during the removal of neoplasms of the thyroid, parathyroid, adrenal, pancreas, paragangliomas and/or extra adrenal neuroendocrine tissue and gastrointestinal neuroendocrine tumors. No investigational therapy will be given. It is anticipated that 1,900 patients will be enrolled over a period of 16 years.

Arms & Interventions

Arms

: 1/ Cohort 1

Subjects with endocrine neoplasm or pre or potentially malignant condition of the endocrine system, scheduled to have surgery or biopsy

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

[email protected]

(240) 858-7033