Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00005927 : Study of Adrenal Gland Tumors
PhaseN/A
AgesMin: 3 Years Max: 70 Years
Eligibility
- INCLUSION CRITERIA:

Patients are adults or children with evidence for the existence of a tumor of the adrenal
glands, as indicated by previously obtained imaging studies and/or biochemical
investigation of hormonal secretion. This condition is meant to include the possibility
of individuals with "sub-clinical" hormone secretion syndromes, which may be detectable at
the biochemical level even in the absence of frank clinical signs/symptoms.

All eligible patients are invited to participate in this protocol, regardless of sex, race
or ethnic origin. All populations appear at risk for adrenal tumors, and therefore the
subject population can include Native Americans, Asian/Pacific Islanders, Caucasian,
Hispanic, and Black individuals. Patients will be accepted for evaluation based on
referral from clinicians, or may be self-referred, if they can provide evidence supportive
of the diagnosis of hormone over-secretion.

Patients must be willing to return to the NIH for follow-up evaluation.

Patients may withdraw from the study at any time.

EXCLUSION CRITERIA:

1. Children less than 3 years old will be excluded from the protocol because of the
limited resources available at the NIH for the care of infants of this age.

2. Individuals over the age of 70 years of age will be excluded because of the
possibility of comorbidities that may significantly affect appropriate initial
work-up and post-operative management. In addition, research data may be compromised
by the inability to interpret data collected from patients over the age of 70 years
that may be on multiple medications for a variety for reasons.

3. Women who are pregnant or nursing will be excluded from the hyperaldosteronism arm of
the protocol. Women with adrenal tumors secreting cortisol or other adrenal hormones
may benefit clinically from evaluation and treatment of their tumor, and will be
considered for enrollment when clinically indicated.

4. Individuals whose medical status will not allow them, for safety reasons, to
participate in the provocative testing or who have unacceptably high risk for
surgical morbidity and mortality will be excluded from the protocol, as they will not
be able to participate profitably in the research aspects of this protocol.

5. Individuals found to have an known inherited syndrome as the cause for hormone
oversecretion will be excluded from participation in this protocol, as the mechanisms
of hormone oversecretion and tumorigenesis is likely to be distinct in these
individuals. Specific examples of syndromes to may be excluded from this protocol
include individuals with Carney Complex, McCune-Albright syndrome, and MEN-1. If
inquiries are received from such patients, they will be referred to the appropriate
ongoing protocols, if possible.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00005927      |      Link to official Clinicaltrials.gov listing
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