Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Sponsor: National Cancer Institute (NCI)
This observational or N/A phase trial investigates Adrenal Neoplasm and Endocrine Tumors and is currently actively recruiting participants. National Cancer Institute (NCI) leads this study, which shows 88 recorded versions since 2009 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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...
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:
Participants 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 participants 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.
Participants must have an ECOG performance score of 0-2.
Participants must have 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 2,300 participants will be followed on this study, however, to account for screening up to 2,415 participants may be enrolled.
Status Flow
Change History
88 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
-
Apr 28, 2026 — May 4, 2026 [daily]
Recruiting
-
Apr 16, 2026 — Apr 28, 2026 [daily]
Recruiting
-
Mar 2026 — Apr 2026 [monthly]
Recruiting
-
Feb 2026 — Mar 2026 [monthly]
Recruiting
▶ Show 83 earlier versions
-
Jan 2026 — Feb 2026 [monthly]
Recruiting
-
Dec 2025 — Jan 2026 [monthly]
Recruiting
-
Nov 2025 — Dec 2025 [monthly]
Recruiting
-
Oct 2025 — Nov 2025 [monthly]
Recruiting
-
Sep 2025 — Oct 2025 [monthly]
Recruiting
-
Aug 2025 — Sep 2025 [monthly]
Recruiting
-
Jul 2025 — Aug 2025 [monthly]
Recruiting
-
Jun 2025 — Jul 2025 [monthly]
Recruiting
-
May 2025 — Jun 2025 [monthly]
Recruiting
-
Apr 2025 — May 2025 [monthly]
Recruiting
-
Mar 2025 — Apr 2025 [monthly]
Recruiting
-
Feb 2025 — Mar 2025 [monthly]
Recruiting
-
Jan 2025 — Feb 2025 [monthly]
Recruiting
-
Dec 2024 — Jan 2025 [monthly]
Recruiting
-
Nov 2024 — Dec 2024 [monthly]
Recruiting
-
Oct 2024 — Nov 2024 [monthly]
Recruiting
-
Sep 2024 — Oct 2024 [monthly]
Recruiting
-
Aug 2024 — Sep 2024 [monthly]
Recruiting
-
Jul 2024 — Aug 2024 [monthly]
Recruiting
-
Jun 2024 — Jul 2024 [monthly]
Recruiting
-
May 2024 — Jun 2024 [monthly]
Recruiting
-
Apr 2024 — May 2024 [monthly]
Recruiting
-
Mar 2024 — Apr 2024 [monthly]
Recruiting
-
Feb 2024 — Mar 2024 [monthly]
Recruiting
-
Jan 2024 — Feb 2024 [monthly]
Recruiting
-
Dec 2023 — Jan 2024 [monthly]
Recruiting
-
Nov 2023 — Dec 2023 [monthly]
Recruiting
-
Oct 2023 — Nov 2023 [monthly]
Recruiting
-
Sep 2023 — Oct 2023 [monthly]
Recruiting
-
Aug 2023 — Sep 2023 [monthly]
Recruiting
-
Jul 2023 — Aug 2023 [monthly]
Recruiting
-
Jun 2023 — Jul 2023 [monthly]
Recruiting
-
May 2023 — Jun 2023 [monthly]
Recruiting
-
Apr 2023 — May 2023 [monthly]
Recruiting
-
Mar 2023 — Apr 2023 [monthly]
Recruiting
-
Feb 2023 — Mar 2023 [monthly]
Recruiting
-
Jan 2023 — Feb 2023 [monthly]
Recruiting
-
Dec 2022 — Jan 2023 [monthly]
Recruiting
-
Nov 2022 — Dec 2022 [monthly]
Recruiting
-
Sep 2022 — Nov 2022 [monthly]
Recruiting
-
Jul 2022 — Sep 2022 [monthly]
Recruiting
-
Jun 2022 — Jul 2022 [monthly]
Recruiting
-
May 2022 — Jun 2022 [monthly]
Recruiting
-
Apr 2022 — May 2022 [monthly]
Recruiting
-
Feb 2022 — Apr 2022 [monthly]
Recruiting
-
Jan 2022 — Feb 2022 [monthly]
Recruiting
-
Dec 2021 — Jan 2022 [monthly]
Recruiting
-
Nov 2021 — Dec 2021 [monthly]
Recruiting
-
Oct 2021 — Nov 2021 [monthly]
Recruiting
-
Sep 2021 — Oct 2021 [monthly]
Recruiting
-
Jun 2021 — Sep 2021 [monthly]
Recruiting
-
May 2021 — Jun 2021 [monthly]
Recruiting
-
Apr 2021 — May 2021 [monthly]
Recruiting
-
Mar 2021 — Apr 2021 [monthly]
Recruiting
-
Feb 2021 — Mar 2021 [monthly]
Recruiting
-
Jan 2021 — Feb 2021 [monthly]
Recruiting
-
Dec 2020 — Jan 2021 [monthly]
Recruiting
-
Sep 2020 — Dec 2020 [monthly]
Recruiting
-
Aug 2020 — Sep 2020 [monthly]
Recruiting
-
May 2020 — Aug 2020 [monthly]
Recruiting
-
Apr 2020 — May 2020 [monthly]
Recruiting
-
Feb 2020 — Apr 2020 [monthly]
Recruiting
-
Jan 2020 — Feb 2020 [monthly]
Recruiting
-
Dec 2019 — Jan 2020 [monthly]
Recruiting
-
Nov 2019 — Dec 2019 [monthly]
Recruiting
-
Oct 2019 — Nov 2019 [monthly]
Recruiting
-
Sep 2019 — Oct 2019 [monthly]
Recruiting
-
Aug 2019 — Sep 2019 [monthly]
Recruiting
-
Jul 2019 — Aug 2019 [monthly]
Recruiting
-
Jun 2019 — Jul 2019 [monthly]
Recruiting
-
Apr 2019 — Jun 2019 [monthly]
Recruiting
-
Mar 2019 — Apr 2019 [monthly]
Recruiting
-
Feb 2019 — Mar 2019 [monthly]
Recruiting
-
Jan 2019 — Feb 2019 [monthly]
Recruiting
-
Nov 2018 — Jan 2019 [monthly]
Recruiting
-
Sep 2018 — Nov 2018 [monthly]
Recruiting
-
Jul 2018 — Sep 2018 [monthly]
Recruiting
-
Jun 2018 — Jul 2018 [monthly]
Recruiting
-
Apr 2018 — Jun 2018 [monthly]
Recruiting
Phase: NA → None
-
Sep 2017 — Apr 2018 [monthly]
Recruiting NA
-
Jun 2017 — Sep 2017 [monthly]
Recruiting NA
-
May 2017 — Jun 2017 [monthly]
Recruiting NA
-
Jan 2017 — May 2017 [monthly]
Recruiting NA
First recorded
Oct 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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 participants 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.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .