Completed

NCT Number: NCT04846647

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

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.)

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Key information

Conditions

Hypophosphatemia Without Immediate Anteriority Unexplained Hypophosphatemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Jean Perrin, Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

unexplained hypophoshatemia

Behavioral

Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care.

Primary outcomes

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

Secondary outcomes

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 ...)
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 ...).

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

DiaSorin ; Saluggia, Italia

Registry information

Acronym: IFEH

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Apr 15, 2021
Registry last updated: May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.