Development of a Predictive Model for the Risk of Metastatic Disease in PPGLs, a Retrospective Cohort Study

Sponsor
Rigshospitalet, Denmark
Study ID
NCT04788927
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 120 Years
Healthy Volunteers
Not accepted

Study Details

Phaeochromocytomas and paragangliomas (PPGLs) are tumours of the adrenal medulla and extra-adrenal sympathetic nervous system, some which can become metastatic. It is a very rare disease and the tumours are often detected late. Approximately 50 % of the tumours are caused by germline genetic variants screening programmes are recommended for patients and their family members; however, they are not yet well-targeted with respect to individual prognosis. In this study the investigatorscaim to characterize the genotype-phenotype associations in all Danish patients (n=400) diagnosed with PPGLs who have been followed in tertiary centres using medical records and national registries. To this end novel immunohistochemical, genetic, and epigenetic biomarkers in tumour tissues samples from biobank material (blood samples and tumour tissue) will be investigated to develop a comprehensive predictive algorithm for disease prognosis. The study will provide a clinical tool for an improved targeted screening program and subsequently prevention of disease development.

Key Dates

First listed
Mar 9, 2021
Start date
Oct 1, 2023
Status verified
Apr 2023
Primary completion
Apr 30, 2024
Completion
Sep 30, 2027

Study Design

Enrollment
400 participants (estimated)

Primary Outcome Measure

Malignant or non-malignant disease [ Time Frame: 25 ys (1996-2021) retrospective data collection of approximately 400 patients until death or until today. ]

Central Contacts

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