Solid Tumor Clinical Trial
— EpidemioPITOfficial title:
Epidemiology of Pituitary Tumours: Prevalence of Associated Endocrine and Non-endocrine Tumours and Potential Implications in the Management and Follow-up of Patients"
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | February 28, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Any patient affected by a documented endocrine pituitary tumour (PiT) - At least one evaluation during the study period (2014-2018) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Neuromed | Pozzilli | IS |
Lead Sponsor | Collaborator |
---|---|
Neuromed IRCCS |
Italy,
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Caimari F, Korbonits M. Novel Genetic Causes of Pituitary Adenomas. Clin Cancer Res. 2016 Oct 15;22(20):5030-5042. Review. — View Citation
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. — View Citation
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. Epub 2006 Sep 12. — View Citation
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, Sabaté MI, Bertagna X, Ga — View Citation
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. — View Citation
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. — View Citation
O'Toole SM, Dénes 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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of hyperparathyroidism (HPT) | measurement of plasma Parathormone (PTH) in % of upper limit of normal values (ULN) | Up to 6 months | |
Primary | Prevalence of hypercalcemia (hypercalcemic hyperparathyroidism) | measurement of calcemia (mg/dl) | Up to 6 months | |
Primary | Search for secondary cause of hyperparathyroidism (1): vit D deficiency | measurement of plasma 25(OH)D (ng/ml) | Up to 6 months (where indicated) | |
Primary | Search for secondary cause of hyperparathyroidism (2): renal failure | measurement of plasma creatinine (mg/dl) | Up to 6 months | |
Primary | Prevalence of thyroid nodules | Thyroid ultrasound | Up to 6 months | |
Primary | Prevalence of other endocrine and non-endocrine neoplasia (1) | Report of any neoplasia before the diagnosis of PiT | Up to 6 months | |
Primary | Prevalence of other endocrine and non-endocrine neoplasia (2) | Report of any neoplasia diagnosed during the follow-up of PiT | Up to 6 months | |
Primary | Familial setting (1) | Report of any available information concerning familiarity for PiT | Up to 6 months | |
Primary | Familial setting (2) | Familiarity for any associated neoplasia | up to 6 months | |
Secondary | Genetics (1) familial forms of PiT | AIP gene sequencing upon genetic counselling | up to 15 months | |
Secondary | Genetics (2) familial PiT and/or association with HPT | MEN1 sequencing upon genetic counselling | up to 15 months | |
Secondary | Genetics (3) any other clinical suspicion for MEN1 | MEN1 gene sequencing upon genetic counselling | up to 15 months | |
Secondary | Genetics (4) any other clinical suspicion of inherited neoplasia syndrome | genetic counselling for appropriate gene sequencing | up to 15 months |
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