LesionsNCT00923780
Evaluation of Blood Vessel Formation in Endocrine Tumors
An observational study of Lesions, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Tumors depend on blood vessels to provide the nourishment that allows them to grow. Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the tumors that contain the most blood vessels. Thus, endocrine tumors are important for the study of new blood vessel formation in tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lesions
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2007to 28 Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients referred to the Endocrine Consult Service with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven, endocrine neoplasms, including lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine rests, 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms
Background:
- Tumors depend on blood vessels to provide the nourishment that allows them to grow.
- Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the tumors that contain the most blood vessels. Thus, endocrine tumors are important for the study of new blood vessel formation in tumors.
Read more
Objectives:
-To obtain tissues from endocrine tumors for examination to determine how they differ from normal tissue.
Eligibility:
-Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue.
Design:
- Tissues will be obtained from patients during surgery to remove thyroid, parathyroid, adrenal, pancreas, or neuroendocrine tumors.
- About 400 patients will be enrolled in the study over a period of 5 years.
Read the detailed description
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 highly vascularized tumors seen.
- Consequently, endocrine neoplasms provide an extremely important model for the study of tumor angiogenesis.
- The Tumor Angiogenesis Section of the Surgery Branch, NCI has a focus on studying neovascular formation in neoplastic tissues. 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 advance our knowledge of the mechanisms involved in tumor vessel development. The majority of the patients enrolled on this study will be patients on other protocols throughout the NIH, for which our Section is consulted in order to perform their surgery.
Objectives:
Primary Objective:
-To develop a class predictor model based on gene expression patterns to distinguish benign from neoplastic endocrine tissue for each of the endocrine histologies under study. This objective will drive the statistical endpoints of the study.
Secondary Objectives:
- To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression changes, proteomic changes, and methylation changes.
- To perform histologic examination of these tissues including immunohistochemistry and in situ hybridization in order to study changes in tumor neovessel formation.
- To obtain, when accessible, adjacent normal endocrine tissue for comparison with the neoplastic tissue.
- 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.
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 rests, 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.
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 extraadrenal rests of neuroendocrine tissue.
- Tissue will be processed at the time of collection, stored and then shipped to the PI's laboratory for further processing.
- No investigational therapy will be given.
- It is anticipated that 400 patients will be enrolled over a period of 5 years.
- Conditions
- Lesions
- Keywords
- Tissue Acquisition, Gene Expression, Class Predictor Model, Endocrine Tumor
- Medical subject headings
- Endocrine Gland Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start5 Jan 2007
- Primary completion28 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LesionsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923780
- Sponsor's protocol ID
- 070060
- Other IDs
- 07-C-0060
- Status last verified
- 28 Sep 2009
- First submitted
- 17 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Mazzanti C, Zeiger MA, Costouros NG, Umbricht C, Westra WH, Smith D, Somervell H, Bevilacqua G, Alexander HR, Libutti SK. Using gene expression profiling to differentiate benign versus malignant thyroid tumors. Cancer Res. 2004 Apr 15;64(8):2898-903. doi: 10.1158/0008-5472.can-03-3811.
PubMed 15087409Libutti SK, Crabtree JS, Lorang D, Burns AL, Mazzanti C, Hewitt SM, O'Connor S, Ward JM, Emmert-Buck MR, Remaley A, Miller M, Turner E, Alexander HR, Arnold A, Marx SJ, Collins FS, Spiegel AM. Parathyroid gland-specific deletion of the mouse Men1 gene results in parathyroid neoplasia and hypercalcemic hyperparathyroidism. Cancer Res. 2003 Nov 15;63(22):8022-8.
PubMed 14633735Bergers G, Javaherian K, Lo KM, Folkman J, Hanahan D. Effects of angiogenesis inhibitors on multistage carcinogenesis in mice. Science. 1999 Apr 30;284(5415):808-12. doi: 10.1126/science.284.5415.808.
PubMed 10221914
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Tumor Angiogenesis in Endocrine Neoplasms
- ClinicalTrials.gov ID
- NCT00923780
- Acronym / sponsor ID
- 070060
- Conditions
- Lesions
- Keywords
- Tissue Acquisition, Gene Expression, Class Predictor Model, Endocrine Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Jan 2007
- Primary completion
- 28 Sep 2009 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Tumors depend on blood vessels to provide the nourishment that allows them to grow.
- Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the tumors that contain the most blood vessels. Thus, endocrine tumors are important for the study of new blood vessel formation in tumors.
Objectives:
-To obtain tissues from endocrine tumors for examination to determine how they differ from normal tissue.
Eligibility:
-Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue.
Design:
- Tissues will be obtained from patients during surgery to remove thyroid, parathyroid, adrenal, pancreas, or neuroendocrine tumors.
- About 400 patients will be enrolled in the study over a period of 5 years.
Detailed description
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 highly vascularized tumors seen.
- Consequently, endocrine neoplasms provide an extremely important model for the study of tumor angiogenesis.
- The Tumor Angiogenesis Section of the Surgery Branch, NCI has a focus on studying neovascular formation in neoplastic tissues. 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 advance our knowledge of the mechanisms involved in tumor vessel development. The majority of the patients enrolled on this study will be patients on other protocols throughout the NIH, for which our Section is consulted in order to perform their surgery.
Objectives:
Primary Objective:
-To develop a class predictor model based on gene expression patterns to distinguish benign from neoplastic endocrine tissue for each of the endocrine histologies under study. This objective will drive the statistical endpoints of the study.
Secondary Objectives:
- To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression changes, proteomic changes, and methylation changes.
- To perform histologic examination of these tissues including immunohistochemistry and in situ hybridization in order to study changes in tumor neovessel formation.
- To obtain, when accessible, adjacent normal endocrine tissue for comparison with the neoplastic tissue.
- 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.
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 rests, 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.
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 extraadrenal rests of neuroendocrine tissue.
- Tissue will be processed at the time of collection, stored and then shipped to the PI's laboratory for further processing.
- No investigational therapy will be given.
- It is anticipated that 400 patients will be enrolled over a period of 5 years.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred to the Endocrine Consult Service with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven, endocrine neoplasms, including lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine rests, 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15087409Mazzanti C, Zeiger MA, Costouros NG, Umbricht C, Westra WH, Smith D, Somervell H, Bevilacqua G, Alexander HR, Libutti SK. Using gene expression profiling to differentiate benign versus malignant thyroid tumors. Cancer Res. 2004 Apr 15;64(8):2898-903. doi: 10.1158/0008-5472.can-03-3811.
- Background: PubMed 14633735Libutti SK, Crabtree JS, Lorang D, Burns AL, Mazzanti C, Hewitt SM, O'Connor S, Ward JM, Emmert-Buck MR, Remaley A, Miller M, Turner E, Alexander HR, Arnold A, Marx SJ, Collins FS, Spiegel AM. Parathyroid gland-specific deletion of the mouse Men1 gene results in parathyroid neoplasia and hypercalcemic hyperparathyroidism. Cancer Res. 2003 Nov 15;63(22):8022-8.
- Background: PubMed 10221914Bergers G, Javaherian K, Lo KM, Folkman J, Hanahan D. Effects of angiogenesis inhibitors on multistage carcinogenesis in mice. Science. 1999 Apr 30;284(5415):808-12. doi: 10.1126/science.284.5415.808.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lesions, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923780, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.