Epidemiology of Pituitary Tumours: Prevalence of Associated Neoplasia

NCT03973450 | Unknown

• 1 other identifier: Neuroendo-1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to update current knowledge about the epidemiology of pituitary tumours (PiT), based on the wide body of scientific literature on new familial and/or syndromic forms. Although inherited predisposition is increasingly recognized, its clinical relevance in unselected series of PiT patients has not been specifically addressed. In addition, it is likely that further recognition of peculiar associations between PiT and other endocrine and/or non-endocrine neoplasia will further increase the spectrum of syndromic forms. Since the identification of inherited forms of PiT may have significant clinical implications in terms of patients management and familial screening, we aim to collect any relevant information in order to estimate their prevalence in a large unselected series of PiT patients and provide new clues for a modern clinical approach to these patients.

Conditions

Pituitary Tumor; Endocrine Neoplasia; Hyperparathyroidism; Solid Tumor; Familial Tumor Syndrome

Outcome Measures

Primary Outcomes (9)

• Prevalence of hyperparathyroidism (HPT)

  measurement of plasma Parathormone (PTH) in % of upper limit of normal values (ULN)

  Up to 6 months

• Prevalence of hypercalcemia (hypercalcemic hyperparathyroidism)

  measurement of calcemia (mg/dl)

  Up to 6 months

• Search for secondary cause of hyperparathyroidism (1): vit D deficiency

  measurement of plasma 25(OH)D (ng/ml)

  Up to 6 months (where indicated)

• Search for secondary cause of hyperparathyroidism (2): renal failure

  measurement of plasma creatinine (mg/dl)

  Up to 6 months

• Prevalence of thyroid nodules

  Thyroid ultrasound

  Up to 6 months

• Prevalence of other endocrine and non-endocrine neoplasia (1)

  Report of any neoplasia before the diagnosis of PiT

  Up to 6 months

• Prevalence of other endocrine and non-endocrine neoplasia (2)

  Report of any neoplasia diagnosed during the follow-up of PiT

  Up to 6 months

• Familial setting (1)

  Report of any available information concerning familiarity for PiT

  Up to 6 months

• Familial setting (2)

  Familiarity for any associated neoplasia

  up to 6 months

Secondary Outcomes (4)

• Genetics (1) familial forms of PiT

  up to 15 months

• Genetics (2) familial PiT and/or association with HPT

  up to 15 months

• Genetics (3) any other clinical suspicion for MEN1

  up to 15 months

• Genetics (4) any other clinical suspicion of inherited neoplasia syndrome

  up to 15 months

Study Arms (1)

Pituitary tumours

Patients affected by pituitary tumours and followed-up at the Neuroendocrinology Unit over a 5 yrs period (2014-2018)

Other: Registration of familial forms and associated neoplasia

Interventions

Registration of familial forms and associated neoplasia OTHER

Retrospective registration of associated endocrine and non-endocrine neoplasia and potential familial setting

Also known as: Genetic counselling where appropriate

Pituitary tumours

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We estimate that more than 500 patients followed at the Neuroendocrinology unit meet the eligibility criteria for the study period, and that a majority of them will accept to enter the study. Patients are affected prevalently by functional pituitary tumours (prolactinomas about 50%, followed by acromegaly about 20%, corticotroph tumours..), others have clinically non-functiong pituitary tumours (about 25%). The large majority of patients are adult (\> 90 %).

You may qualify if:

• Any patient affected by a documented endocrine pituitary tumour (PiT)
• At least one evaluation during the study period (2014-2018)

You may not qualify if:

• Uncertain diagnosis of endocrine pituitary tumour
• Any adult patient declining to enter the study
• For the (few) patients aged less than 18 years, parents or legal tutors declining to include the patient in the study

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

Neuromed

Pozzilli, IS, 86077, Italy

RECRUITING

Related Publications (13)

• Daly AF, Rixhon M, Adam C, Dempegioti A, Tichomirowa MA, Beckers A. High prevalence of pituitary adenomas: a cross-sectional study in the province of Liege, Belgium. J Clin Endocrinol Metab. 2006 Dec;91(12):4769-75. doi: 10.1210/jc.2006-1668. Epub 2006 Sep 12.

  PMID: 16968795 BACKGROUND

• Fernandez A, Karavitaki N, Wass JA. Prevalence of pituitary adenomas: a community-based, cross-sectional study in Banbury (Oxfordshire, UK). Clin Endocrinol (Oxf). 2010 Mar;72(3):377-82. doi: 10.1111/j.1365-2265.2009.03667.x. Epub 2009 Jul 24.

  PMID: 19650784 BACKGROUND

• Caimari F, Korbonits M. Novel Genetic Causes of Pituitary Adenomas. Clin Cancer Res. 2016 Oct 15;22(20):5030-5042. doi: 10.1158/1078-0432.CCR-16-0452.

  PMID: 27742789 BACKGROUND

• Corbetta S, Pizzocaro A, Peracchi M, Beck-Peccoz P, Faglia G, Spada A. Multiple endocrine neoplasia type 1 in patients with recognized pituitary tumours of different types. Clin Endocrinol (Oxf). 1997 Nov;47(5):507-12. doi: 10.1046/j.1365-2265.1997.3311122.x.

  PMID: 9425388 BACKGROUND

• Alrezk R, Hannah-Shmouni F, Stratakis CA. MEN4 and CDKN1B mutations: the latest of the MEN syndromes. Endocr Relat Cancer. 2017 Oct;24(10):T195-T208. doi: 10.1530/ERC-17-0243. Epub 2017 Aug 19.

  PMID: 28824003 BACKGROUND

• Thakker RV, Newey PJ, Walls GV, Bilezikian J, Dralle H, Ebeling PR, Melmed S, Sakurai A, Tonelli F, Brandi ML; Endocrine Society. Clinical practice guidelines for multiple endocrine neoplasia type 1 (MEN1). J Clin Endocrinol Metab. 2012 Sep;97(9):2990-3011. doi: 10.1210/jc.2012-1230. Epub 2012 Jun 20.

  PMID: 22723327 BACKGROUND

• Olsson DS, Hammarstrand C, Bryngelsson IL, Nilsson AG, Andersson E, Johannsson G, Ragnarsson O. Incidence of malignant tumours in patients with a non-functioning pituitary adenoma. Endocr Relat Cancer. 2017 May;24(5):227-235. doi: 10.1530/ERC-16-0518. Epub 2017 Mar 8.

  PMID: 28274953 BACKGROUND

• Terzolo M, Reimondo G, Berchialla P, Ferrante E, Malchiodi E, De Marinis L, Pivonello R, Grottoli S, Losa M, Cannavo S, Ferone D, Montini M, Bondanelli M, De Menis E, Martini C, Puxeddu E, Velardo A, Peri A, Faustini-Fustini M, Tita P, Pigliaru F, Peraga G, Borretta G, Scaroni C, Bazzoni N, Bianchi A, Berton A, Serban AL, Baldelli R, Fatti LM, Colao A, Arosio M; Italian Study Group of Acromegaly. Acromegaly is associated with increased cancer risk: a survey in Italy. Endocr Relat Cancer. 2017 Sep;24(9):495-504. doi: 10.1530/ERC-16-0553. Epub 2017 Jul 14.

  PMID: 28710115 BACKGROUND

• O'Toole SM, Denes J, Robledo M, Stratakis CA, Korbonits M. 15 YEARS OF PARAGANGLIOMA: The association of pituitary adenomas and phaeochromocytomas or paragangliomas. Endocr Relat Cancer. 2015 Aug;22(4):T105-22. doi: 10.1530/ERC-15-0241. Epub 2015 Jun 25.

  PMID: 26113600 BACKGROUND

• Beckers A, Aaltonen LA, Daly AF, Karhu A. Familial isolated pituitary adenomas (FIPA) and the pituitary adenoma predisposition due to mutations in the aryl hydrocarbon receptor interacting protein (AIP) gene. Endocr Rev. 2013 Apr;34(2):239-77. doi: 10.1210/er.2012-1013. Epub 2013 Jan 31.

  PMID: 23371967 BACKGROUND

• Bilezikian JP, Bandeira L, Khan A, Cusano NE. Hyperparathyroidism. Lancet. 2018 Jan 13;391(10116):168-178. doi: 10.1016/S0140-6736(17)31430-7. Epub 2017 Sep 17.

  PMID: 28923463 BACKGROUND

• Jaffrain-Rea ML, Daly AF, Angelini M, Petrossians P, Bours V, Beckers A. Genetic susceptibility in pituitary adenomas: from pathogenesis to clinical implications. Expert Rev Endocrinol Metab. 2011 Mar;6(2):195-214. doi: 10.1586/eem.10.87.

  PMID: 30290451 RESULT

• Daly AF, Vanbellinghen JF, Khoo SK, Jaffrain-Rea ML, Naves LA, Guitelman MA, Murat A, Emy P, Gimenez-Roqueplo AP, Tamburrano G, Raverot G, Barlier A, De Herder W, Penfornis A, Ciccarelli E, Estour B, Lecomte P, Gatta B, Chabre O, Sabate MI, Bertagna X, Garcia Basavilbaso N, Stalldecker G, Colao A, Ferolla P, Wemeau JL, Caron P, Sadoul JL, Oneto A, Archambeaud F, Calender A, Sinilnikova O, Montanana CF, Cavagnini F, Hana V, Solano A, Delettieres D, Luccio-Camelo DC, Basso A, Rohmer V, Brue T, Bours V, Teh BT, Beckers A. Aryl hydrocarbon receptor-interacting protein gene mutations in familial isolated pituitary adenomas: analysis in 73 families. J Clin Endocrinol Metab. 2007 May;92(5):1891-6. doi: 10.1210/jc.2006-2513. Epub 2007 Jan 23.

  PMID: 17244780 RESULT

MeSH Terms

Conditions

Pituitary Neoplasms; Endocrine Gland Neoplasms; Hyperparathyroidism; Neoplastic Syndromes, Hereditary

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Parathyroid Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marie-Lise Jaffrain-Rea, MD

  Neuromed IRCCS, Pozzilli (IS), Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Lise Jaffrain-Rea, MD

CONTACT

+393487813716; marielise.jaffrain@univaq.it

Alba Di Pardo, MD

CONTACT

+393483631480; dipardoa@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: June 4, 2019
• Study Start: June 15, 2019
• Primary Completion: November 30, 2021
• Study Completion: February 28, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)