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Epidemiology of Pituitary Tumours: Prevalence of Associated Neoplasia (EpidemioPIT)

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ClinicalTrials.gov Identifier: NCT03973450
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Marie-Lise Jaffrain-Rea, MD, Neuromed IRCCS

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.

Condition or disease Intervention/treatment
Pituitary Tumor Endocrine Neoplasia Hyperparathyroidism Solid Tumor Familial Tumor Syndrome Other: Registration of familial forms and associated neoplasia

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
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"
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Retrospective registration of associated endocrine and non-endocrine neoplasia and potential familial setting
Other Name: Genetic counselling where appropriate




Primary Outcome Measures :
  1. Prevalence of hyperparathyroidism (HPT) [ Time Frame: Up to 6 months ]
    measurement of plasma Parathormone (PTH) in % of upper limit of normal values (ULN)

  2. Prevalence of hypercalcemia (hypercalcemic hyperparathyroidism) [ Time Frame: Up to 6 months ]
    measurement of calcemia (mg/dl)

  3. 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)

  4. Search for secondary cause of hyperparathyroidism (2): renal failure [ Time Frame: Up to 6 months ]
    measurement of plasma creatinine (mg/dl)

  5. Prevalence of thyroid nodules [ Time Frame: Up to 6 months ]
    Thyroid ultrasound

  6. Prevalence of other endocrine and non-endocrine neoplasia (1) [ Time Frame: Up to 6 months ]
    Report of any neoplasia before the diagnosis of PiT

  7. 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

  8. Familial setting (1) [ Time Frame: Up to 6 months ]
    Report of any available information concerning familiarity for PiT

  9. Familial setting (2) [ Time Frame: up to 6 months ]
    Familiarity for any associated neoplasia


Secondary Outcome Measures :
  1. Genetics (1) familial forms of PiT [ Time Frame: up to 15 months ]
    AIP gene sequencing upon genetic counselling

  2. Genetics (2) familial PiT and/or association with HPT [ Time Frame: up to 15 months ]
    MEN1 sequencing upon genetic counselling

  3. Genetics (3) any other clinical suspicion for MEN1 [ Time Frame: up to 15 months ]
    MEN1 gene sequencing upon genetic counselling

  4. Genetics (4) any other clinical suspicion of inherited neoplasia syndrome [ Time Frame: up to 15 months ]
    genetic counselling for appropriate gene sequencing



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 %).
Criteria

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

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): NCT03973450


Contacts
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Contact: Marie-Lise Jaffrain-Rea, MD +393487813716 marielise.jaffrain@univaq.it
Contact: Alba Di Pardo, MD +393483631480 dipardoa@hotmail.com

Sponsors and Collaborators
Neuromed IRCCS
Investigators
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Principal Investigator: Marie-Lise Jaffrain-Rea, MD Neuromed IRCCS, Pozzilli (IS), Italy

Publications of Results:
Other Publications:

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Responsible Party: Marie-Lise Jaffrain-Rea, MD, Associate Professor of Endocrinology, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT03973450     History of Changes
Other Study ID Numbers: Neuroendo-1
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
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
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Endocrine Gland Neoplasms
Neoplastic Syndromes, Hereditary
Hyperparathyroidism
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Genetic Diseases, Inborn