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Development of a Predictive Model for the Risk of Metastatic Disease in PPGLs, a Retrospective Cohort Study (PPGL-Pred)

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ClinicalTrials.gov Identifier: NCT04788927
Recruitment Status : Not yet recruiting
First Posted : March 9, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease
Paraganglioma Pheochromocytoma Genetic Predisposition to Disease Pathology Somatic Mutation Head and Neck Cancer Neuroendocrine Tumors

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of a Comprehensive Predictive Model for Risk of Metastatic Disease in PPGLs Based on a Combination of Clinical, Biochemical, Genetic, and Pathoanatomical Characteristics a Retrospective National Cohort Study
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : September 30, 2027





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


Biospecimen Retention:   Samples With DNA
Blood samples and tumour tissue samples from existing biobanks.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Location: Nation-wide cohort of all patients followed in one of the tertiary hospitals: Copenhagen (Rigshospitalet), Århus (Skejby) and Odense University hospital.

Identification: The patients will be retrieved from the National Danish Registry of Hospital Diagnoses by use of their national identification number (CPR).

Criteria

Inclusion Criteria:

  • All Danish patients diagnosed with PPGLs or genetic variants that predispose to PPGLs since 1996 will be included.

Exclusion Criteria:

  • None from the initial data collection. If there are no tumour tissue or blood samples from a patient in the biobanks they will subsequently be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788927


Contacts
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Contact: Ulla Feldt-Rasmussen, Professor +45 35451023 ufeldt@rh.dk
Contact: Ailsa Maria Main, MD +45 27125249 ailsa.maria.main.02@regionh.dk

Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
National University Hospital, Department of Medical Endocrinology
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Ulla Feldt-Rasmussen, Prof., Dr. med. Rigshospitalet, Denmark
Publications:
Pacak K, Tella SH. Pheochromocytoma and Paraganglioma. In: De Groot LJ, Chrousos G, Dungan K, et al., eds. Endotext. South Dartmouth MA: MDText.com, Inc.; 2000
Lloyd RV OR, Klöppel G, Rosai J. WHO Classification of Tumours of Endocrine Organs 4th ed. Lyon IARC; 2017
Capper D, Jones DTW, Sill M, Hovestadt V, Schrimpf D, Sturm D, Koelsche C, Sahm F, Chavez L, Reuss DE, Kratz A, Wefers AK, Huang K, Pajtler KW, Schweizer L, Stichel D, Olar A, Engel NW, Lindenberg K, Harter PN, Braczynski AK, Plate KH, Dohmen H, Garvalov BK, Coras R, Hölsken A, Hewer E, Bewerunge-Hudler M, Schick M, Fischer R, Beschorner R, Schittenhelm J, Staszewski O, Wani K, Varlet P, Pages M, Temming P, Lohmann D, Selt F, Witt H, Milde T, Witt O, Aronica E, Giangaspero F, Rushing E, Scheurlen W, Geisenberger C, Rodriguez FJ, Becker A, Preusser M, Haberler C, Bjerkvig R, Cryan J, Farrell M, Deckert M, Hench J, Frank S, Serrano J, Kannan K, Tsirigos A, Brück W, Hofer S, Brehmer S, Seiz-Rosenhagen M, Hänggi D, Hans V, Rozsnoki S, Hansford JR, Kohlhof P, Kristensen BW, Lechner M, Lopes B, Mawrin C, Ketter R, Kulozik A, Khatib Z, Heppner F, Koch A, Jouvet A, Keohane C, Mühleisen H, Mueller W, Pohl U, Prinz M, Benner A, Zapatka M, Gottardo NG, Driever PH, Kramm CM, Müller HL, Rutkowski S, von Hoff K, Frühwald MC, Gnekow A, Fleischhack G, Tippelt S, Calaminus G, Monoranu CM, Perry A, Jones C, Jacques TS, Radlwimmer B, Gessi M, Pietsch T, Schramm J, Schackert G, Westphal M, Reifenberger G, Wesseling P, Weller M, Collins VP, Blümcke I, Bendszus M, Debus J, Huang A, Jabado N, Northcott PA, Paulus W, Gajjar A, Robinson GW, Taylor MD, Jaunmuktane Z, Ryzhova M, Platten M, Unterberg A, Wick W, Karajannis MA, Mittelbronn M, Acker T, Hartmann C, Aldape K, Schüller U, Buslei R, Lichter P, Kool M, Herold-Mende C, Ellison DW, Hasselblatt M, Snuderl M, Brandner S, Korshunov A, von Deimling A, Pfister SM. DNA methylation-based classification of central nervous system tumours. Nature. 2018 Mar 22;555(7697):469-474. doi: 10.1038/nature26000. Epub 2018 Mar 14.

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Responsible Party: Ulla Feldt-Rasmussen, Professor Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04788927    
Other Study ID Numbers: PPGL-Pred
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark:
Paraganglioma
Phaeochromocytoma
Clinical genetics
Pathology
Translational research
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Pheochromocytoma
Neoplasm Metastasis
Paraganglioma
Carotid Body Tumor
Genetic Predisposition to Disease
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Disease Susceptibility
Disease Attributes
Pathologic Processes
Neoplastic Processes
Paraganglioma, Extra-Adrenal