Tumor Induced Oncogenic OsteomalaciaNCT02331966
Molecular Pathways Involved in the Pathogenesis and Behavior of Mesenchymal Phosphaturic Tumors Causing Oncogenic Osteomalacia
An observational study of Tumor Induced Oncogenic Osteomalacia, run by AHEPA University Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor Induced Oncogenic Osteomalacia
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tumor induced osteomalacia
Who may be able to join
- Patients with tumor induced osteomalacia
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
1st Department of Internal Medicine AHEPA University Hospital
Thessaloniki, 54636
Michael Daniilidis, M.D, 00302310993202, daniilidis@gmail.com
John G. Yovos, M.D, 00302310994607, giovos@med.auth.gr
About this study
Official title: Molecular Pathways Involved in the Pathogenesis and Behavior of Mesenchymal Phosphaturic Tumors
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.
- Conditions
- Tumor Induced Oncogenic Osteomalacia
- Keywords
- FGF-23, GROWTH FACTORS RECEPTORS, RECURRENCES
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression of Molecular pathways in tumors inducing oncogenic osteomalacia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Induced Oncogenic OsteomalaciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Yavropoulou, AHEPA University Hospital
- Investigators
- Maria P. Yavropoulou, M.D, Principal investigator, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331966
- Sponsor's protocol ID
- 51741
- Status last verified
- Jan 2015
- First submitted
- 5 Jan 2015
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Pathways Involved in the Pathogenesis and Behavior of Mesenchymal Phosphaturic Tumors
- ClinicalTrials.gov ID
- NCT02331966
- Acronym / sponsor ID
- 51741
- Conditions
- Tumor Induced Oncogenic Osteomalacia
- Keywords
- FGF-23, GROWTH FACTORS RECEPTORS, RECURRENCES
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tumor induced osteomalacia
Key inclusion criteria (1 listed)
- Patients with tumor induced osteomalacia
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differential expression of Molecular pathways in tumors inducing oncogenic osteomalacia
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria P. Yavropoulou, M.D principal investigator
AHEPA University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor Induced Oncogenic Osteomalacia, run by AHEPA University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Daniilidis, M.D (00302310993202, daniilidis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential expression of Molecular pathways in tumors inducing oncogenic osteomalacia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.