Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 4 - 100 |
| Updated: | 3/30/2019 |
| Start Date: | October 7, 2009 |
| Contact: | Claudia P Derse-Anthony |
| Email: | ncieobinquiry@mail.nih.gov |
| Phone: | (240) 760-6102 |
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.
- 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.
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 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 predicitive
markers as well as therapeutic targets that may have significant cilinical
ramifications.
Objectives:
- 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 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 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 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,
and paragangliomas and or extraadrenal nests of neuroendocrine tissue.
- 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,
and paragangliomas and or extraadrenal neuroendocrine tissue.
- No investigational therapy will be given.
- It is anticipated that 1350 patients will be enrolled over a period of 16 years.
- 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 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 predicitive
markers as well as therapeutic targets that may have significant cilinical
ramifications.
Objectives:
- 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 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 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 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,
and paragangliomas and or extraadrenal nests of neuroendocrine tissue.
- 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,
and paragangliomas and or extraadrenal neuroendocrine tissue.
- No investigational therapy will be given.
- It is anticipated that 1350 patients will be enrolled over a period of 16 years.
- 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 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 301-402-4395
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