PheochromocytomaNCT00001229
Diagnosis and Treatment of Pheochromocytoma
An observational study of Pheochromocytoma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not cancerous) and can be cured by surgical removal. However, pheochromocytomas produce neurohormones called cateholamines (epinephrine and norepinephrine). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pheochromocytoma
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1988to Jan 2001
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Patients of any age and either sex who are suspected of having a pheochromocytoma on the basis of one or more of the following: 1. hypertensive episodes in a normotensive subject, 2. abnormal levels of blood and/or urinary catecholamines or their metabolites, or 3. an otherwise unexplained abdominal mass.
Patients without any evidence of pheochromocytoma are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not cancerous) and can be cured by surgical removal. However, pheochromocytomas produce neurohormones called cateholamines (epinephrine and norepinephrine). High levels of catecholamines can result in high blood pressure, headaches, sweating, heart palpitations, nausea, vomiting, and other symptoms. These tumors are considered dangerous because of their unpredictable behavior. Patients with pheochromocytoma may experience blood pressures high enough to cause a stroke or heart attack in patients.
This study is designed to take patients suspected of having pheochromocytoma and confirm the diagnosis. This will be done using a variety of laboratory tests including a clonidine suppression test and glucagon stimulation test. These tests use drugs that can stimulate or reduce the activity of the tumor if it is present in the body.
Once a diagnosis is confirmed, patients participating in this study will undergo standard procedures to find the exact location of the tumor and receive standard therapy for the condition.
Read the detailed description
Patients suspected of having a pheochromocytoma will be studied via a series of tests in an attempt to ascertain biochemically whether or not they really have such a tumor. These procedures will include a standard clonidine suppression test and a standard glucagon stimulation test. Once the diagnosis has been made on the basis of biochemistry, then localization and therapy will be done via standard procedures. Measurement of plasma metanephrines on mailed samples is available for physicians who seek further evidence for the diagnosis of pheochromocytoma.
- Conditions
- Pheochromocytoma
- Keywords
- Calcium-Pentagastrin, Clonidine, Glucagon, Pheochromocytoma
- Medical subject headings
- Pheochromocytoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startOct 1988
- Study completionJan 2001
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 PheochromocytomaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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
- Enrolment
- 240 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001229
- Sponsor's protocol ID
- 880189
- Other IDs
- 88-H-0189
- Status last verified
- Nov 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Elijovich F. Plasma metanephrines in the diagnosis of pheochromocytoma. Ann Intern Med. 1996 Apr 1;124(7):694-5. doi: 10.7326/0003-4819-124-7-199604010-00019. No abstract available.
PubMed 8607605Grossman E, Goldstein DS, Hoffman A, Keiser HR. Glucagon and clonidine testing in the diagnosis of pheochromocytoma. Hypertension. 1991 Jun;17(6 Pt 1):733-41. doi: 10.1161/01.hyp.17.6.733.
PubMed 2045133Amery A, Conway J. A critical review of diagnostic tests for pheochromocytoma. Am Heart J. 1967 Jan;73(1):129-33. doi: 10.1016/0002-8703(67)90318-3. No abstract available.
PubMed 5333928
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Pheochromocytoma
- ClinicalTrials.gov ID
- NCT00001229
- Acronym / sponsor ID
- 880189
- Conditions
- Pheochromocytoma
- Keywords
- Calcium-Pentagastrin, Clonidine, Glucagon, Pheochromocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Oct 1988
- Study completion
- Jan 2001
- First posted
- 10 Dec 2002 (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.
Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not cancerous) and can be cured by surgical removal. However, pheochromocytomas produce neurohormones called cateholamines (epinephrine and norepinephrine). High levels of catecholamines can result in high blood pressure, headaches, sweating, heart palpitations, nausea, vomiting, and other symptoms. These tumors are considered dangerous because of their unpredictable behavior. Patients with pheochromocytoma may experience blood pressures high enough to cause a stroke or heart attack in patients.
This study is designed to take patients suspected of having pheochromocytoma and confirm the diagnosis. This will be done using a variety of laboratory tests including a clonidine suppression test and glucagon stimulation test. These tests use drugs that can stimulate or reduce the activity of the tumor if it is present in the body.
Once a diagnosis is confirmed, patients participating in this study will undergo standard procedures to find the exact location of the tumor and receive standard therapy for the condition.
Detailed description
Patients suspected of having a pheochromocytoma will be studied via a series of tests in an attempt to ascertain biochemically whether or not they really have such a tumor. These procedures will include a standard clonidine suppression test and a standard glucagon stimulation test. Once the diagnosis has been made on the basis of biochemistry, then localization and therapy will be done via standard procedures. Measurement of plasma metanephrines on mailed samples is available for physicians who seek further evidence for the diagnosis of pheochromocytoma.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 4 Mar 2008.
- Background: PubMed 8607605Elijovich F. Plasma metanephrines in the diagnosis of pheochromocytoma. Ann Intern Med. 1996 Apr 1;124(7):694-5. doi: 10.7326/0003-4819-124-7-199604010-00019. No abstract available.
- Background: PubMed 2045133Grossman E, Goldstein DS, Hoffman A, Keiser HR. Glucagon and clonidine testing in the diagnosis of pheochromocytoma. Hypertension. 1991 Jun;17(6 Pt 1):733-41. doi: 10.1161/01.hyp.17.6.733.
- Background: PubMed 5333928Amery A, Conway J. A critical review of diagnostic tests for pheochromocytoma. Am Heart J. 1967 Jan;73(1):129-33. doi: 10.1016/0002-8703(67)90318-3. No abstract available.
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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 Pheochromocytoma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 NCT00001229, 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 4 Mar 2008.