ALLNCT05592470
commd7 Gene Expression in ALL
An observational study of ALL, run by Assiut University.
Trial summary
study the expression pattern of COMMD7 gene in acute lymphoblastic leukemia. investigate correlation between the expression level of COMMD7 gene with other diagnostic parameters and prognosis in ALL . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALL
- What is being tested?
- Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The required sample size will be 102 subject (51 newly diagnosed patients with ALL and 51 controls )
Who may be able to join
- Patients newly diagnosed with acute lymphoblastic leukemia , male or female at any age.
Who cannot join
- history of anti-neoplastic therapy, such as chemotherapy or radiotherapy.
- Any other types of cancers.
- Any clinically systemic acute or chronic inflammatory disease/s within one months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Copper Metabolism MURR1 Domain 7 (COMMD7) Gene Expression in Acute Lymphoblastic Leukemia
- study the expression pattern of COMMD7 gene in acute lymphoblastic leukemia.
- investigate correlation between the expression level of COMMD7 gene with other diagnostic parameters and prognosis in ALL .
Read the detailed description
Acute lymphoblastic leukemia (ALL) is a neoplastic disorder of lymphoid progenitor cells characterized by diverse cytogenetic and molecular abnormalities with peaks of prevalence for 2-5-year-old patients and those older than 50. Treatment strategies using risk-adapted chemotherapy cure more than 80% of childhood cases, but around 20 to 30% relapse developing serious complications including death.( 1) In the past decade, the available treatments for patients with acute lymphoblastic leukemia (ALL) have rapidly expanded, in parallel with an increased understanding of the genomic features that impact the disease biology and clinical outcomes.(2) The copper metabolism MURR1 domain (COMMD) protein family involved in tumor development and progression in several types of human cancer, but little is known about the function of COMMD proteins in hematological malignancy. (3) COMMD7, a member of the COMMD, which is located on chromosome 20q11.21, has been reported associated with tumor progression in human solid cancers [4]. COMMD7 is overexpressed in pancreatic ductal adenocarcinoma (PDAC) cells, associated with poor prognosis. [5]. Another study revealed that COMMD7-overexpressed hepatocellular carcinoma (HCC) cells promoted the proliferation of naïve HCC cells (6) A recent study was found that high expression of COMMD7 is a potential biomarker for adverse outcomes and poor prognosis in AML. (7)
. However, to date, the expression of COMMD7 in acute lymphoblastic leukemia and its prognostic value remain unclear.
- Conditions
- ALL
- Being tested
- Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).
- Keywords
- COMMD7 , ALL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).Diagnostic test
Reverse transcription-quantitative polymerase chain reaction on bone marrow aspirates to detect The expression pattern of COMMD7 gene in acute lymphoblastic leukemia
| Study group | Role | What they receive |
|---|---|---|
| PATEINTS | 51 patients newly diagnosed with acute lymphoblastic leukemia Receives: Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR). | |
| controls | 51 normal persons Receives: Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression pattern of COMMD7 gene in acute lymphoblastic leukemia
Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) TO DETECT EXPRESSION pattern in ALL
Measured: BASELINE
Secondary outcomes (1)
Correlation between the expression level of COMMD7 GENE with other diagnostic parameters and prognosis in ALL
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ALLStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Saad Mohamed Mahrous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592470
- Sponsor's protocol ID
- commd7 gene expression in ALL
- Status last verified
- Sep 2022
- First submitted
- 20 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
Publications
Garza-Veloz I, Martinez-Fierro ML, Jaime-Perez JC, Carrillo-Sanchez K, Ramos-Del Hoyo MG, Lugo-Trampe A, Rojas-Martinez A, Gutierrez-Aguirre CH, Gonzalez-Llano O, Salazar-Riojas R, Hidalgo-Miranda A, Gomez-Almaguer D, Ortiz-Lopez R. Identification of differentially expressed genes associated with prognosis of B acute lymphoblastic leukemia. Dis Markers. 2015;2015:828145. doi: 10.1155/2015/828145. Epub 2015 Feb 24.
PubMed 25802479Short NJ, Kantarjian H, Jabbour E. Optimizing the treatment of acute lymphoblastic leukemia in younger and older adults: new drugs and evolving paradigms. Leukemia. 2021 Nov;35(11):3044-3058. doi: 10.1038/s41375-021-01277-3. Epub 2021 Jun 25.
PubMed 34172894Bartuzi P, Hofker MH, van de Sluis B. Tuning NF-kappaB activity: a touch of COMMD proteins. Biochim Biophys Acta. 2013 Dec;1832(12):2315-21. doi: 10.1016/j.bbadis.2013.09.014. Epub 2013 Sep 29.
PubMed 24080195Burstein E, Hoberg JE, Wilkinson AS, Rumble JM, Csomos RA, Komarck CM, Maine GN, Wilkinson JC, Mayo MW, Duckett CS. COMMD proteins, a novel family of structural and functional homologs of MURR1. J Biol Chem. 2005 Jun 10;280(23):22222-32. doi: 10.1074/jbc.M501928200. Epub 2005 Mar 30.
PubMed 15799966You N, Li J, Gong Z, Huang X, Wang W, Wang L, Wu K, Zheng L. COMMD7 functions as molecular target in pancreatic ductal adenocarcinoma. Mol Carcinog. 2017 Feb;56(2):607-624. doi: 10.1002/mc.22520. Epub 2016 Jul 8.
PubMed 27350032You N, Li J, Huang X, Wu K, Tang Y, Wang L, Li H, Mi N, Zheng L. COMMD7 promotes hepatocellular carcinoma through regulating CXCL10. Biomed Pharmacother. 2017 Apr;88:653-657. doi: 10.1016/j.biopha.2017.01.046. Epub 2017 Jan 29.
PubMed 28142122Li K, Chen L, Zhang H, Wang L, Sha K, Du X, Li D, Zheng Z, Pei R, Lu Y, Tong H. High expression of COMMD7 is an adverse prognostic factor in acute myeloid leukemia. Aging (Albany NY). 2021 Apr 23;13(8):11988-12006. doi: 10.18632/aging.202901. Epub 2021 Apr 23.
PubMed 33891561
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Copper Metabolism MURR1 Domain 7 (COMMD7) Gene Expression in Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05592470
- Acronym / sponsor ID
- commd7 gene expression in ALL
- Conditions
- ALL
- Keywords
- COMMD7 , ALL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 24 Oct 2022 (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.
- study the expression pattern of COMMD7 gene in acute lymphoblastic leukemia.
- investigate correlation between the expression level of COMMD7 gene with other diagnostic parameters and prognosis in ALL .
Detailed description
Acute lymphoblastic leukemia (ALL) is a neoplastic disorder of lymphoid progenitor cells characterized by diverse cytogenetic and molecular abnormalities with peaks of prevalence for 2-5-year-old patients and those older than 50. Treatment strategies using risk-adapted chemotherapy cure more than 80% of childhood cases, but around 20 to 30% relapse developing serious complications including death.( 1) In the past decade, the available treatments for patients with acute lymphoblastic leukemia (ALL) have rapidly expanded, in parallel with an increased understanding of the genomic features that impact the disease biology and clinical outcomes.(2) The copper metabolism MURR1 domain (COMMD) protein family involved in tumor development and progression in several types of human cancer, but little is known about the function of COMMD proteins in hematological malignancy. (3) COMMD7, a member of the COMMD, which is located on chromosome 20q11.21, has been reported associated with tumor progression in human solid cancers [4]. COMMD7 is overexpressed in pancreatic ductal adenocarcinoma (PDAC) cells, associated with poor prognosis. [5]. Another study revealed that COMMD7-overexpressed hepatocellular carcinoma (HCC) cells promoted the proliferation of naïve HCC cells (6) A recent study was found that high expression of COMMD7 is a potential biomarker for adverse outcomes and poor prognosis in AML. (7)
. However, to date, the expression of COMMD7 in acute lymphoblastic leukemia and its prognostic value remain unclear.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATEINTS | – | Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).51 patients newly diagnosed with acute lymphoblastic leukemia |
| controls | – | Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).51 normal persons |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The required sample size will be 102 subject (51 newly diagnosed patients with ALL and 51 controls )
Key inclusion criteria (1 listed)
- Patients newly diagnosed with acute lymphoblastic leukemia , male or female at any age.
Key exclusion criteria (3 listed)
- history of anti-neoplastic therapy, such as chemotherapy or radiotherapy.
- Any other types of cancers.
- Any clinically systemic acute or chronic inflammatory disease/s within one months.
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 |
|---|---|---|
| Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).Reverse transcription-quantitative polymerase chain reaction on bone marrow aspirates to detect The expression pattern of COMMD7 gene in acute lymphoblastic leukemia | Diagnostic test | PATEINTS, controls |
Primary outcome
The expression pattern of COMMD7 gene in acute lymphoblastic leukemia
Time frame: BASELINE
Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) TO DETECT EXPRESSION pattern in ALL
1 secondary outcome
Correlation between the expression level of COMMD7 GENE with other diagnostic parameters and prognosis in ALL
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 25802479Garza-Veloz I, Martinez-Fierro ML, Jaime-Perez JC, Carrillo-Sanchez K, Ramos-Del Hoyo MG, Lugo-Trampe A, Rojas-Martinez A, Gutierrez-Aguirre CH, Gonzalez-Llano O, Salazar-Riojas R, Hidalgo-Miranda A, Gomez-Almaguer D, Ortiz-Lopez R. Identification of differentially expressed genes associated with prognosis of B acute lymphoblastic leukemia. Dis Markers. 2015;2015:828145. doi: 10.1155/2015/828145. Epub 2015 Feb 24.
- Background: PubMed 34172894Short NJ, Kantarjian H, Jabbour E. Optimizing the treatment of acute lymphoblastic leukemia in younger and older adults: new drugs and evolving paradigms. Leukemia. 2021 Nov;35(11):3044-3058. doi: 10.1038/s41375-021-01277-3. Epub 2021 Jun 25.
- Background: PubMed 24080195Bartuzi P, Hofker MH, van de Sluis B. Tuning NF-kappaB activity: a touch of COMMD proteins. Biochim Biophys Acta. 2013 Dec;1832(12):2315-21. doi: 10.1016/j.bbadis.2013.09.014. Epub 2013 Sep 29.
- Background: PubMed 15799966Burstein E, Hoberg JE, Wilkinson AS, Rumble JM, Csomos RA, Komarck CM, Maine GN, Wilkinson JC, Mayo MW, Duckett CS. COMMD proteins, a novel family of structural and functional homologs of MURR1. J Biol Chem. 2005 Jun 10;280(23):22222-32. doi: 10.1074/jbc.M501928200. Epub 2005 Mar 30.
- Background: PubMed 27350032You N, Li J, Gong Z, Huang X, Wang W, Wang L, Wu K, Zheng L. COMMD7 functions as molecular target in pancreatic ductal adenocarcinoma. Mol Carcinog. 2017 Feb;56(2):607-624. doi: 10.1002/mc.22520. Epub 2016 Jul 8.
- Background: PubMed 28142122You N, Li J, Huang X, Wu K, Tang Y, Wang L, Li H, Mi N, Zheng L. COMMD7 promotes hepatocellular carcinoma through regulating CXCL10. Biomed Pharmacother. 2017 Apr;88:653-657. doi: 10.1016/j.biopha.2017.01.046. Epub 2017 Jan 29.
- Background: PubMed 33891561Li K, Chen L, Zhang H, Wang L, Sha K, Du X, Li D, Zheng Z, Pei R, Lu Y, Tong H. High expression of COMMD7 is an adverse prognostic factor in acute myeloid leukemia. Aging (Albany NY). 2021 Apr 23;13(8):11988-12006. doi: 10.18632/aging.202901. Epub 2021 Apr 23.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ALL, 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 3 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 24 Oct 2022. 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?
Contact marwa saad mohamed, master (0201003860750, qmarwa_1989@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression pattern of COMMD7 gene in acute lymphoblastic leukemia (time frame: BASELINE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592470, which also lists 7 linked publications.
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 24 Oct 2022.