Pituitary TumorEpidemioPITNCT03973450
Epidemiology of Pituitary Tumours: Prevalence of Associated Neoplasia
An observational study of Pituitary Tumor and Endocrine Neoplasia, run by Neuromed IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Tumor, Endocrine Neoplasia, Hyperparathyroidism
- What is being tested?
- Registration of familial forms and associated neoplasia
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 %).
Who may be able to join
- Any patient affected by a documented endocrine pituitary tumour (PiT)
- At least one evaluation during the study period (2014-2018)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Neuromed
Pozzilli, IS, 86077
Marie-Lise Jaffrain-Rea, MD, +393487813716, marielise.jaffrain@univaq.it
Alba Di Pardo, PhD, +393483631480, alba.dipardo78@gmail.com
About this study
Official 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.
Read the detailed description
Recent epidemiological studies indicate that clinically relevant PiT have a prevalence around 1%. The Neuromed Scientific Institute for Research and Cure (IRCCS) is a third referral center for the diagnosis and treatment of patients with hypothalamic-pituitary disorders, and PiT represent the most frequent condition.
The best known syndromic of PiT is Multiple Endocrine Neoplasia type 1 (MEN1), others are rare conditions, such as MEN1-like syndromes, Carney complex, Mc Cune Albright syndrome, the pheochromocytoma/paraganglioma/Pit syndrome. Apparently isolated familial forms of PiT (FIPA) have also been well characterized in the last decade.The genetics of inherited PiT is involving a growing number of genes.At the moment, the most frequently reported gene abnormalities consist of inactivating mutations of the MEN1 and Aryl hydrocarbon receptor Interacting Protein (AIP) genes, which are mainly observed in syndromic and isolated familial forms of PiT, respectively.
On the other hand, patients affected by growth-hormone (GH)-secreting PiT (acromegaly/gigantism) have an increased risk of associated neoplasia, which has been mainly attributed to the growth-promoting effects of GH and/or Insulin-like Growth Factor 1(IGF1). However, a variety of neoplasia have been recently observed in patients with non-functioning PiT, whereas patients affected by prolactinoma - the most common PiT phenotype - have been poorly studied. Associations between PiT and a variety of neoplasia may represent new forms of systemic forms of PiT.
The aim of the study is to evaluate the prevalence of endocrine and non-endocrine neoplasia in a large series of PiTpatients and to identify potential familial and syndromic forms, including new forms of tumor associations, in order to provide new insights in the epidemiology and genetics of PiT and evaluate their clinical relevance in daily practice.
Eligible patients will receive a detailed informative form about the aim, methods and potential implications of the study. They will be included upon written informed consent and be re-assured that they may refuse to participate or withdraw from the study at any time, without any prejudice in their clinical management.
Data will be collected retrospectively in patients followed-up in the last 5 years, when an increased awareness of systemic conditions has lead, in the respect of good clinical practice, to a systematic registration of familiarity for PiT and/or for associated neoplasia. As clinically recommended, most patients have been screened at least once for primary hyperparathyroidism (pHPT), which is the most prevalent endocrine tumor in MEN1, and thyroid ultrasound, which is generally proposed as an extension of any endocrinological visit. Therefore, parathyroid and/or thyroid tumours should have been correctly identified in a large majority of patients. In contrast, except for systemic search for colonic polyps or tumours by coloscopy in acromegalic patients, and screening for breast and colon cancer performed by the patients in the setting of the Italian National Health System (NHS) programme since the age of 50 yr-old, no systematic search for additional tumours was performed and diagnoses were typically made by the general practitioner and other specialists.
Any relevant clinical, biological or imaging data about PiT and extrapituitary tumours will be collected for each patients.
All data will be collected anonymously in a dedicated Excel file.
Statistical analysis will be performed with using a commercially available software - JMP version 11.0 distributed by Statistical Analysis Systems (SAS) (USA). The first part of the report will be descriptive, report all endocrine and non-endocrine neoplasia and potential familiarity for PiT and/or any other associated neoplasia. Then, a comparison will be made between groups and subgroups of PiT patients defined according to the PiT phenotype (functioning and nonfunctioning PiT subgroups, tumour volume and invasiveness), as well as gender, age and the presence of a familial setting. Based on public reports of the Italian registry of cancer (AIRTUM), an attempt will be made to compare the prevalence of the most frequent neoplasia in PiT patients with the general population. Attention will be paid to recognize syndromic forms of PiT, including known syndromes and new forms of associations between PiT and any endocrine or non-endocrine neoplasia.
Genetic evaluation and counselling will be proposed in selected cases, based on evaluation of the clinical picture with the specialist in clinical genetics present in the study team. A specific additional consent will be necessary to proceed to the genetic step and DNA conservation for further studies where appropriate. Leukocyte DNA will be collected by blood sampling. Diagnostic genetic testing will be appropriately performed according to the clinical presentation. For unknown associations, this study is intended to be preliminary to further genetic studies aiming to identify new candidate genes.
- Conditions
- Pituitary Tumor, Endocrine Neoplasia, Hyperparathyroidism, Solid Tumor, Familial Tumor Syndrome
- Being tested
- Registration of familial forms and associated neoplasia
- Medical subject headings
- Pituitary Neoplasms, Endocrine Gland Neoplasms, Hyperparathyroidism, Neoplastic Syndromes, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration of familial forms and associated neoplasiaOther
Also called Genetic counselling where appropriate
Retrospective registration of associated endocrine and non-endocrine neoplasia and potential familial setting
| Study group | Role | What they receive |
|---|---|---|
| Pituitary tumours | Patients affected by pituitary tumours and followed-up at the Neuroendocrinology Unit over a 5 yrs period (2014-2018) Receives: Other: Registration of familial forms and associated neoplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hyperparathyroidism (HPT)
measurement of plasma Parathormone (PTH) in % of upper limit of normal values (ULN)
Measured: Up to 6 months
Prevalence of hypercalcemia (hypercalcemic hyperparathyroidism)
measurement of calcemia (mg/dl)
Measured: Up to 6 months
Search for secondary cause of hyperparathyroidism (1): vit D deficiency
measurement of plasma 25(OH)D (ng/ml)
Measured: Up to 6 months (where indicated)
Search for secondary cause of hyperparathyroidism (2): renal failure
measurement of plasma creatinine (mg/dl)
Measured: Up to 6 months
Prevalence of thyroid nodules
Thyroid ultrasound
Measured: Up to 6 months
Prevalence of other endocrine and non-endocrine neoplasia (1)
Report of any neoplasia before the diagnosis of PiT
Measured: Up to 6 months
Prevalence of other endocrine and non-endocrine neoplasia (2)
Report of any neoplasia diagnosed during the follow-up of PiT
Measured: Up to 6 months
Familial setting (1)
Report of any available information concerning familiarity for PiT
Measured: Up to 6 months
Familial setting (2)
Familiarity for any associated neoplasia
Measured: up to 6 months
Secondary outcomes (4)
Genetics (1) familial forms of PiT
AIP gene sequencing upon genetic counselling
Measured: up to 15 months
Genetics (2) familial PiT and/or association with HPT
MEN1 sequencing upon genetic counselling
Measured: up to 15 months
Genetics (3) any other clinical suspicion for MEN1
MEN1 gene sequencing upon genetic counselling
Measured: up to 15 months
Genetics (4) any other clinical suspicion of inherited neoplasia syndrome
genetic counselling for appropriate gene sequencing
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start15 Jun 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Lise Jaffrain-Rea, MD, Neuromed IRCCS
- Investigators
- Marie-Lise Jaffrain-Rea, MD, Principal investigator, Neuromed IRCCS, Pozzilli (IS), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973450
- Sponsor's protocol ID
- Neuroendo-1
- Acronym
- EpidemioPIT
- Status last verified
- Aug 2021
- First submitted
- 25 May 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16968795Fernandez 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.
PubMed 19650784Caimari 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.
PubMed 27742789Corbetta 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.
PubMed 9425388Alrezk 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.
PubMed 28824003Thakker 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.
PubMed 22723327Olsson 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.
PubMed 28274953Terzolo 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.
PubMed 28710115O'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.
PubMed 26113600Beckers 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.
PubMed 23371967Bilezikian 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.
PubMed 28923463Jaffrain-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.
PubMed 30290451Daly 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.
PubMed 17244780
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Pituitary Tumours: Prevalence of Associated Endocrine and Non-endocrine Tumours and Potential Implications in the Management and Follow-up of Patients"
- ClinicalTrials.gov ID
- NCT03973450
- Acronym / sponsor ID
- EpidemioPIT / Neuroendo-1
- Conditions
- Pituitary Tumor, Endocrine Neoplasia, Hyperparathyroidism, Solid Tumor, Familial Tumor Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recent epidemiological studies indicate that clinically relevant PiT have a prevalence around 1%. The Neuromed Scientific Institute for Research and Cure (IRCCS) is a third referral center for the diagnosis and treatment of patients with hypothalamic-pituitary disorders, and PiT represent the most frequent condition.
The best known syndromic of PiT is Multiple Endocrine Neoplasia type 1 (MEN1), others are rare conditions, such as MEN1-like syndromes, Carney complex, Mc Cune Albright syndrome, the pheochromocytoma/paraganglioma/Pit syndrome. Apparently isolated familial forms of PiT (FIPA) have also been well characterized in the last decade.The genetics of inherited PiT is involving a growing number of genes.At the moment, the most frequently reported gene abnormalities consist of inactivating mutations of the MEN1 and Aryl hydrocarbon receptor Interacting Protein (AIP) genes, which are mainly observed in syndromic and isolated familial forms of PiT, respectively.
On the other hand, patients affected by growth-hormone (GH)-secreting PiT (acromegaly/gigantism) have an increased risk of associated neoplasia, which has been mainly attributed to the growth-promoting effects of GH and/or Insulin-like Growth Factor 1(IGF1). However, a variety of neoplasia have been recently observed in patients with non-functioning PiT, whereas patients affected by prolactinoma - the most common PiT phenotype - have been poorly studied. Associations between PiT and a variety of neoplasia may represent new forms of systemic forms of PiT.
The aim of the study is to evaluate the prevalence of endocrine and non-endocrine neoplasia in a large series of PiTpatients and to identify potential familial and syndromic forms, including new forms of tumor associations, in order to provide new insights in the epidemiology and genetics of PiT and evaluate their clinical relevance in daily practice.
Eligible patients will receive a detailed informative form about the aim, methods and potential implications of the study. They will be included upon written informed consent and be re-assured that they may refuse to participate or withdraw from the study at any time, without any prejudice in their clinical management.
Data will be collected retrospectively in patients followed-up in the last 5 years, when an increased awareness of systemic conditions has lead, in the respect of good clinical practice, to a systematic registration of familiarity for PiT and/or for associated neoplasia. As clinically recommended, most patients have been screened at least once for primary hyperparathyroidism (pHPT), which is the most prevalent endocrine tumor in MEN1, and thyroid ultrasound, which is generally proposed as an extension of any endocrinological visit. Therefore, parathyroid and/or thyroid tumours should have been correctly identified in a large majority of patients. In contrast, except for systemic search for colonic polyps or tumours by coloscopy in acromegalic patients, and screening for breast and colon cancer performed by the patients in the setting of the Italian National Health System (NHS) programme since the age of 50 yr-old, no systematic search for additional tumours was performed and diagnoses were typically made by the general practitioner and other specialists.
Any relevant clinical, biological or imaging data about PiT and extrapituitary tumours will be collected for each patients.
All data will be collected anonymously in a dedicated Excel file.
Statistical analysis will be performed with using a commercially available software - JMP version 11.0 distributed by Statistical Analysis Systems (SAS) (USA). The first part of the report will be descriptive, report all endocrine and non-endocrine neoplasia and potential familiarity for PiT and/or any other associated neoplasia. Then, a comparison will be made between groups and subgroups of PiT patients defined according to the PiT phenotype (functioning and nonfunctioning PiT subgroups, tumour volume and invasiveness), as well as gender, age and the presence of a familial setting. Based on public reports of the Italian registry of cancer (AIRTUM), an attempt will be made to compare the prevalence of the most frequent neoplasia in PiT patients with the general population. Attention will be paid to recognize syndromic forms of PiT, including known syndromes and new forms of associations between PiT and any endocrine or non-endocrine neoplasia.
Genetic evaluation and counselling will be proposed in selected cases, based on evaluation of the clinical picture with the specialist in clinical genetics present in the study team. A specific additional consent will be necessary to proceed to the genetic step and DNA conservation for further studies where appropriate. Leukocyte DNA will be collected by blood sampling. Diagnostic genetic testing will be appropriately performed according to the clinical presentation. For unknown associations, this study is intended to be preliminary to further genetic studies aiming to identify new candidate genes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pituitary tumours | – | Other: Registration of familial forms and associated neoplasiaPatients affected by pituitary tumours and followed-up at the Neuroendocrinology Unit over a 5 yrs period (2014-2018) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 %).
Key inclusion criteria (2 listed)
- Any patient affected by a documented endocrine pituitary tumour (PiT)
- At least one evaluation during the study period (2014-2018)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registration of familial forms and associated neoplasiaAlso: Genetic counselling where appropriateRetrospective registration of associated endocrine and non-endocrine neoplasia and potential familial setting | Other | Pituitary tumours |
Primary outcome
Prevalence of hyperparathyroidism (HPT)
Time frame: Up to 6 months
measurement of plasma Parathormone (PTH) in % of upper limit of normal values (ULN)
Prevalence of hypercalcemia (hypercalcemic hyperparathyroidism)
Time frame: Up to 6 months
measurement of calcemia (mg/dl)
Search for secondary cause of hyperparathyroidism (1): vit D deficiency
Time frame: Up to 6 months (where indicated)
measurement of plasma 25(OH)D (ng/ml)
Search for secondary cause of hyperparathyroidism (2): renal failure
Time frame: Up to 6 months
measurement of plasma creatinine (mg/dl)
Prevalence of thyroid nodules
Time frame: Up to 6 months
Thyroid ultrasound
Prevalence of other endocrine and non-endocrine neoplasia (1)
Time frame: Up to 6 months
Report of any neoplasia before the diagnosis of PiT
Prevalence of other endocrine and non-endocrine neoplasia (2)
Time frame: Up to 6 months
Report of any neoplasia diagnosed during the follow-up of PiT
Familial setting (1)
Time frame: Up to 6 months
Report of any available information concerning familiarity for PiT
Familial setting (2)
Time frame: up to 6 months
Familiarity for any associated neoplasia
4 secondary outcomes
Genetics (1) familial forms of PiT
Time frame: up to 15 months
Genetics (2) familial PiT and/or association with HPT
Time frame: up to 15 months
Genetics (3) any other clinical suspicion for MEN1
Time frame: up to 15 months
Genetics (4) any other clinical suspicion of inherited neoplasia syndrome
Time frame: up to 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 16968795Daly 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.
- Background: PubMed 19650784Fernandez 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.
- Background: PubMed 27742789Caimari 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.
- Background: PubMed 9425388Corbetta 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.
- Background: PubMed 28824003Alrezk 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.
- Background: PubMed 22723327Thakker 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.
- Background: PubMed 28274953Olsson 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.
- Background: PubMed 28710115Terzolo 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.
- Background: PubMed 26113600O'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.
- Background: PubMed 23371967Beckers 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.
- Background: PubMed 28923463Bilezikian 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.
- Results publication: PubMed 30290451Jaffrain-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Lise Jaffrain-Rea, MD principal investigator
Neuromed IRCCS, Pozzilli (IS), Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Tumor and Endocrine Neoplasia, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Lise Jaffrain-Rea, MD (+393487813716, marielise.jaffrain@univaq.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hyperparathyroidism (HPT) (time frame: Up to 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973450, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.