ClinicalTrials.gg
Status unknownNCT02331966Updated Jan 6, 2015

Molecular Pathways Involved in the Pathogenesis and Behavior of Mesenchymal Phosphaturic Tumors Causing Oncogenic Osteomalacia

An observational study in Tumor Induced Oncogenic Osteomalacia, sponsored by AHEPA University Hospital. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-01-06.

Primary conditionnone(registry's first term: Recurrence)No conditionIs this wrong?Recurrence describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by AHEPA University Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 80 Years
Sex
All
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Study summary

The tumors that cause oncogenic osteomalacia (TIO) express and release in the circulation phosphaturic factors such as fibroblast growth factor-23 (FGF-23) that decrease renal phosphate absorption through acting in the proximal renal tubule and decreasing Type 2a and 2c sodium-phosphate co-transporter. They typically follow a benign clinical course and even in the rare malignant cases, local recurrence occurs in less than 5% and distant metastasis are very uncommon.

In this study we aim to investigate the role of other molecular pathways such as ERK1, ERK2, mTOR, EGFR, MEK1, MEK2, VEGFR3, AKT1, AKT2, IGFR-1, IGFR-2, PDGFRA, PDGFRB, cMET, FGFR2, apart from FGF23, KLOTHO and PHEX, in the behavior of histopathologically benign mesenchymal phosphaturic tumors.

Read the detailed description

Study Protocol Cell Culture Bone marrow and tissue samples will be obtained from the patients after they will give their written informed consent. Material will be maintained in RPMI culture medium (Sigma, R0883, Germany). Peripheral blood mononuclear cells (PBMCs) from healthy donors will be used as control. For detection of cancer cells in our samples we perform flow cytometry using EpCAM magnetic beads (39-EPC-50; Gentaur), and the negative selection cells (non-cancerous) are isolated and then cultured in a 25-cm2 flask (5520100; Orange Scientific) with RPMI-1640 medium (R6504; Sigma).

Molecular analysis RNA is extracted from cell cultures using RNeasy Mini Kit (74105; Qiagen, Hilden; Germany). iScript cDNA synthesis kit (1708891; Bio-Rad, CA; USA), is used for cDNA synthesis and Real-time polymerase chain reaction (PCR), is performed using the iTaq Universal SYBR Green Supermix (1725124; Bio-Rad). Specific primers for each marker and for an endogenous control gene (18S rRNA) is designed using Genamic Expression 1.1 software. A universal Reference RNA consisting of 10 human cancer cell lines (740000-41; Agilent) as well as human genomic DNA (G304A; Promega) will be used in quantitative PCR (qPCR) reactions Statistical analysis The qPCR results will be tested according to the Kolmogorov-Smirnov test; All the reactions (molecular assays, flow cytometry) are performed in triplicates. A p value \<0.05 is considered significant.

02

Conditions studied

  • Tumor Induced Oncogenic Osteomalacia

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Keywords

  • FGF-23
  • GROWTH FACTORS RECEPTORS
  • RECURRENCES
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In context

Lead sponsor

AHEPA University Hospital is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with tumor induced osteomalacia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with tumor induced osteomalacia

Exclusion criteria

Exclusion Criteria:

None

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Differential expression of Molecular pathways in tumors inducing oncogenic osteomalacia

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • 1st Department of Internal Medicine AHEPA University Hospital
    Thessaloniki, 54636, Greece
    Recruiting
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Dec 2016 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2015
First posted
Jan 6, 2015
Start
Sep 2014
Primary completionEst.
Dec 2016
CompletionEst.
Mar 2017
Last update
Jan 6, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02331966
Lead sponsor
AHEPA University Hospital
Responsible party
Maria Yavropoulou (Dr, AHEPA University Hospital) — Principal investigator
First posted
Jan 6, 2015
Start date
Sep 2014
Primary completion
Dec 2016 (estimated)
Completion
Mar 2017 (estimated)
Last update
Jan 6, 2015

Study contacts

Michael Daniilidis, M.D
Contact
daniilidis@gmail.com
00302310993202
John G. Yovos, M.D
Contact
giovos@med.auth.gr
00302310994607
Maria P. Yavropoulou, M.D
principal investigator · AHEPA University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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