Multiple MyelomaNCT04212858
Amplification of Zinc Finger Protein 217 Gene in Multiple Myeloma
A study testing zinc-finger protein 217 gene in people with Multiple Myeloma, run by Assiut University.
Trial summary
Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- zinc-finger protein 217 gene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Feb 2022
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed multiple myeloma patients, who fulfill the WHO criteria of myeloma diagnosis.
Who cannot join
- Patients with any other type of malignant or benign tumors should be excluded from our study.
About this study
Official title: Amplification of Zinc- Finger Protein 217 Gene in Multiple Myeloma Patients as a Prognostic Marker
Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors .
Read the detailed description
Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) . MM is the second most common hematologic malignancy and is expected to cause ∼13 000 new cases and 30 000 deaths in 2018. Myeloma is a genetically complex disorder characterized by multiple genetic changes, affecting different pathways, that have the ability to deregulate plasma cell biology leading to a broadly similar phenotypic manifestation of disease. From a genetic perspective, myeloma can be divided into those with and without a hyperdiploid karyotype .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors . This region also contains several oncogenes thought to confer selective advantages to cancer cells. Increased copy numbers of ZNF217 have been reported in various tumors and linked to poor outcome in some studies . ZNF217 can attenuate apoptotic signals resulting from telomere dysfunction and may promote neoplastic transformation and later stages of malignancy. ZNF217 was shown to be a prognostic biomarker and therapeutic target during breast cancer progression. In our best knowledge, No studies were done to detect ZNF217 in multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- zinc-finger protein 217 gene
- Keywords
- Zinc finger 217 protein gene ., Multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc-finger protein 217 geneGenetic
search for zinc-finger protein 217 gene in myeloma patients
| Study group | Role | What they receive |
|---|---|---|
| case | Experimental | myeloma patients Receives: Genetic: zinc-finger protein 217 gene |
| control | Experimental | healthy control Receives: Genetic: zinc-finger protein 217 gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
zinc-finger protein gene 217 in myeloma patients
Measurement of amplification of Zinc-finger protein 217 gene in Multiple myeloma patients as a prognostic marker by fluorescence in situ hybridization technique
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 posted30 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohammed ebrahim tawfik, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212858
- Sponsor's protocol ID
- Zinc finger protein 217 gene
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplification of Zinc- Finger Protein 217 Gene in Multiple Myeloma Patients as a Prognostic Marker
- ClinicalTrials.gov ID
- NCT04212858
- Acronym / sponsor ID
- Zinc finger protein 217 gene
- Conditions
- Multiple Myeloma
- Keywords
- Zinc finger 217 protein gene ., Multiple myeloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 30 Dec 2019 (actual)
- 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.
Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors .
Detailed description
Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) . MM is the second most common hematologic malignancy and is expected to cause ∼13 000 new cases and 30 000 deaths in 2018. Myeloma is a genetically complex disorder characterized by multiple genetic changes, affecting different pathways, that have the ability to deregulate plasma cell biology leading to a broadly similar phenotypic manifestation of disease. From a genetic perspective, myeloma can be divided into those with and without a hyperdiploid karyotype .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors . This region also contains several oncogenes thought to confer selective advantages to cancer cells. Increased copy numbers of ZNF217 have been reported in various tumors and linked to poor outcome in some studies . ZNF217 can attenuate apoptotic signals resulting from telomere dysfunction and may promote neoplastic transformation and later stages of malignancy. ZNF217 was shown to be a prognostic biomarker and therapeutic target during breast cancer progression. In our best knowledge, No studies were done to detect ZNF217 in multiple myeloma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | Experimental | Genetic: zinc-finger protein 217 genemyeloma patients |
| control | Experimental | Genetic: zinc-finger protein 217 genehealthy control |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed multiple myeloma patients, who fulfill the WHO criteria of myeloma diagnosis.
Key exclusion criteria (1 listed)
- Patients with any other type of malignant or benign tumors should be excluded from our study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc-finger protein 217 genesearch for zinc-finger protein 217 gene in myeloma patients | Genetic | case, control |
Primary outcome
zinc-finger protein gene 217 in myeloma patients
Time frame: 2 years
Measurement of amplification of Zinc-finger protein 217 gene in Multiple myeloma patients as a prognostic marker by fluorescence in situ hybridization technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing zinc-finger protein 217 gene in people with Multiple Myeloma, run by Assiut University.
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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
zinc-finger protein gene 217 in myeloma patients (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 30 Dec 2019.