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A multicenter prospective study of biochemical profiles of monoamine-producing tumors: utility for diagnosis and determinants of clinical presentation. (The PMT study)

A multicenter prospective study of biochemical profiles of monoamine-producing tumors: utility for diagnosis and determinants of clinical presentation. (The PMT study) - The PMT study: Prospective Monoamine-producing Tumor study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36293
Enrollment
800
Registered
2012-02-07
Start date
2013-02-15
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertensie pheochromocytoma

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female patients (all ages, including children above 5 yr) with suspected pheochromocytoma/paraganglioma if they fulfill one or more of the are following criteria: (i) patients with a previous history of PPGLs. (ii) new onset of hypertension or therapy-resistant hypertension or hypertensive episodes and/or symptoms suggestive of PPGLs. (iii) family history of PPGL or genetic mutations known to predispose individuals to develop PPGLs. (iv) presence of an accidently found adrenal tumor (v) any other reasonable clinical suspicion of a PPGL ;For establishing reference intervals the following patients will be enrolled: (i) treated or untreated male and female patients with primary hypertension (>140/90 mm Hg) (above 18 yr). (ii) healthy normotensive volunteers (above 18 yr)

Exclusion criteria

Exclusion criteria: • Patients with impaired mental capacity that precludes informed consent. • Subjects who need medications that may interfere with or invalidate outcome parameters (e.g., tricyclic antidepressants). • Pregnancy does not constitute criteria for exclusion from the protocol. However, in pregnant women no PET scanning, MIBG scanning or contrast CT will be performed. • Patients at risk from injury from the MRI magnet due to implantable metal or who suffer from anxiety in enclosed spaces are excluded from MRI.

Design outcomes

Primary

MeasureTime frame
• Numbers of true-positive, false-positive, true-negative and false-negative results of each biochemical test. • Biochemical, metabolic, molecular and secretory profiles as related to the clinical manifestations, malignant development and germline mutations. • Blood pressure profiles, cardiac function parameters and indices of disease progression.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)