Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia (IFEH)

May 10, 2023 updated by: University Hospital, Clermont-Ferrand

The discovery of FGF23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. By inhibiting the renal reabsorption of phosphate and the production of calcitriol, FGF23 behaves like a hypophosphatemia hormone.

Hypersecretion of FGF23 can occur in the case of genetic abnormalities (X-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, McCune-Albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). Oncogenic osteomalacia can be induced by hyperproduction of FGF23 by benign tumours of mesenchymal origin. But more recently, several cases of malignant tumours secreting FGF23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To date, even if the incidence of FGF23-secreting tumours seems rare, no precise bibliographical data is available in the scientific literature. Future studies will have to address this issue in order not to underestimate the frequency of this complication.

In this context, investigators would like to study the incidence of inappropriate FGF23 increase from a collection of biological samples carried out on 500 patients treated at the Clermont-Ferrand University Hospital for hypophosphatemia.

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont Ferrand
      • Clermont-Ferrand, France
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Major patient, male or female with hypophosphatemia (< 0.80 mmol/L), without immediate anteriority

Description

Inclusion Criteria:

  • Major patient, male or female
  • Taken care of at the Clermont-Ferrand University Hospital or the Jean Perrin Centre
  • In a context of hypophosphatemia (< 0.80 mmol/L), without immediate anteriority and not occurring during hospitalisation
  • In capacity to express informed consent to participate in research
  • Affiliated to a social security system

Exclusion Criteria:

  • Previously diagnosed hypophosphatemia
  • Hypophosphatemia during hospitalisation
  • Haemodialysis patient
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unexplained hypophosphatemia
Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care.
Behavioral: unexplained hypophoshatemia
Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the frequency of blood levels of FGF23 unsuitable for hypophosphatemia
Time Frame: day 0
Assessing the presence of a blood level of FGF23 considered unsuitable for hypophosphatemia
day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the relationship between blood levels of FGF23 and other biochemical parameters in hospital patients with hypophosphatemia..
Time Frame: Day 1
Description: Measure blood levels of FGF23 in absolute value and other biochemical parameters (phosphatemia, phosphaturia, PTH, vitamin D ...)
Day 1
Investigate the relationship between blood levels of FGF23 and other biochemical parameters in hospital patients with hypophosphatemia.
Time Frame: day 1
Measure blood levels of FGF23 in absolute value and other biochemical parameters (phosphatemia, phosphaturia, PTH, vitamin D ...).
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

DiaSorin ; Saluggia, Italia

Investigators

  • Principal Investigator: Damien BOUVIER, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

April 25, 2022

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 BOUVIER
  • 2021-A00284-37 (Other Identifier: 2021-A00284-37)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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