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

NCT ID: NCT04846647

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-04-25

Brief Summary

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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.)

Detailed Description

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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.

Conditions

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Hypophosphatemia Without Immediate Anteriority Unexplained Hypophosphatemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Unexplained hypophosphatemia

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

unexplained hypophoshatemia

Intervention Type BEHAVIORAL

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

Interventions

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unexplained hypophoshatemia

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DiaSorin ; Saluggia, Italia

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damien BOUVIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Suvannasankha A, Tompkins DR, Edwards DF, Petyaykina KV, Crean CD, Fournier PG, Parker JM, Sandusky GE, Ichikawa S, Imel EA, Chirgwin JM. FGF23 is elevated in multiple myeloma and increases heparanase expression by tumor cells. Oncotarget. 2015 Aug 14;6(23):19647-60. doi: 10.18632/oncotarget.3794.

Reference Type BACKGROUND
PMID: 25944690 (View on PubMed)

Imel EA, Biggin A, Schindeler A, Munns CF. FGF23, Hypophosphatemia, and Emerging Treatments. JBMR Plus. 2019 May 13;3(8):e10190. doi: 10.1002/jbm4.10190. eCollection 2019 Aug.

Reference Type BACKGROUND
PMID: 31485552 (View on PubMed)

Endo I, Fukumoto S, Ozono K, Namba N, Inoue D, Okazaki R, Yamauchi M, Sugimoto T, Minagawa M, Michigami T, Nagai M, Matsumoto T. Nationwide survey of fibroblast growth factor 23 (FGF23)-related hypophosphatemic diseases in Japan: prevalence, biochemical data and treatment. Endocr J. 2015;62(9):811-6. doi: 10.1507/endocrj.EJ15-0275. Epub 2015 Jul 1.

Reference Type BACKGROUND
PMID: 26135520 (View on PubMed)

Other Identifiers

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2021-A00284-37

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2021 BOUVIER

Identifier Type: -

Identifier Source: org_study_id

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