Chronic Myeloid Leukemia, Chronic PhaseNCT05543161
"Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"
An observational study of Chronic Myeloid Leukemia, Chronic Phase, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic myeloid leukemia (CML) is a stem cell (SC) neoplasm which originates from an incomplete process of differentiation of the hematopoietic stem cells (HSCs) to the adult cells which lead to accumulation of their immature form into the BM and the peripheral blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2022to Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All suspected patients for CML diagnosis aged more than 18 years who presented with high white blood cells(WBCs) count , marked shift to left in peripheral blood with or without splenomegaly .
Who may be able to join
- : All suspected patients for CML diagnosis aged more than 18 years who presented with high white blood cells(WBCs) count , marked shift to left in peripheral blood with or without splenomegaly .
Who cannot join
- Patients on treatment or presence of blasts in peripheral blood sample.
Trial locations and contacts
1 site in 1 country.
DR. Shaaban Helal, professor contact
Egypt1 site
Sohag University Hospital
Sohag
Magdy M Amin Amin, professor, 01002019899, portal@med.sohag.edu.eg
About this study
Chronic myeloid leukemia (CML) is a stem cell (SC) neoplasm which originates from an incomplete process of differentiation of the hematopoietic stem cells (HSCs) to the adult cells which lead to accumulation of their immature form into the BM and the peripheral blood. It is characterized by the reciprocal translocation. The resulting oncoprotein, BCR/ABL1, is considered essential for the initiation and manifestation of the disease . In CML, leukemic stem cell (LSC) supposedly resides within the CD45+/ CD34+/CD38-/Lin- fraction of the leukemic clone (3). However, normal hematopoietic SC also exhibit this phenotype so that additional markers are required to discriminate CML LSC from normal SC. CD34+/CD38-/Lin- CML LSC specifically co-express dipeptidylpeptidase IV(DPPIV=CD26). This enzyme disrupts LSC-niche interactions by degrading stroma derived factor-1 (SDF-1). Moreover, CD26 is a robust biomarker for the quantification and isolation of CML LSC (4). It was reported that CD26+ LSCs were significantly correlated with BCR-ABL1 transcript level at diagnosis and after three months of treatment with tyrosine kinase inhibitor (TKI) .
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Blood Dipeptidylpeptidase IV (CD26)
to detect CD26+ LSCs by flow cytometry for accurate diagnosis of CML patients from peripheral blood sample to reduce the need for Bone Marrow aspiration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid Leukemia, Chronic PhaseStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rowaida Moahmed Mohamed, Sohag University
- Investigators
- Eid, Principal investigator, Sohag univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543161
- Sponsor's protocol ID
- Soh-Med-22-09-10
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lane SW, Scadden DT, Gilliland DG. The leukemic stem cell niche: current concepts and therapeutic opportunities. Blood. 2009 Aug 6;114(6):1150-7. doi: 10.1182/blood-2009-01-202606. Epub 2009 Apr 28.
PubMed 19401558Ebian HF, Abdelnabi AM, Abdelazem AS, Khamis T, Fawzy HM, Hussein S. Peripheral blood CD26 positive leukemic stem cells as a possible diagnostic and prognostic marker in chronic myeloid leukemia. Leuk Res Rep. 2022 May 9;17:100321. doi: 10.1016/j.lrr.2022.100321. eCollection 2022.
PubMed 35602932Waumans Y, Baerts L, Kehoe K, Lambeir AM, De Meester I. The Dipeptidyl Peptidase Family, Prolyl Oligopeptidase, and Prolyl Carboxypeptidase in the Immune System and Inflammatory Disease, Including Atherosclerosis. Front Immunol. 2015 Aug 7;6:387. doi: 10.3389/fimmu.2015.00387. eCollection 2015.
PubMed 26300881Lee SA, Kim YR, Yang EJ, Kwon EJ, Kim SH, Kang SH, Park DB, Oh BC, Kim J, Heo ST, Koh G, Lee DH. CD26/DPP4 levels in peripheral blood and T cells in patients with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Jun;98(6):2553-61. doi: 10.1210/jc.2012-4288. Epub 2013 Mar 28.
PubMed 23539735
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"
- ClinicalTrials.gov ID
- NCT05543161
- Acronym / sponsor ID
- Soh-Med-22-09-10
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 16 Sep 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.
Chronic myeloid leukemia (CML) is a stem cell (SC) neoplasm which originates from an incomplete process of differentiation of the hematopoietic stem cells (HSCs) to the adult cells which lead to accumulation of their immature form into the BM and the peripheral blood. It is characterized by the reciprocal translocation. The resulting oncoprotein, BCR/ABL1, is considered essential for the initiation and manifestation of the disease . In CML, leukemic stem cell (LSC) supposedly resides within the CD45+/ CD34+/CD38-/Lin- fraction of the leukemic clone (3). However, normal hematopoietic SC also exhibit this phenotype so that additional markers are required to discriminate CML LSC from normal SC. CD34+/CD38-/Lin- CML LSC specifically co-express dipeptidylpeptidase IV(DPPIV=CD26). This enzyme disrupts LSC-niche interactions by degrading stroma derived factor-1 (SDF-1). Moreover, CD26 is a robust biomarker for the quantification and isolation of CML LSC (4). It was reported that CD26+ LSCs were significantly correlated with BCR-ABL1 transcript level at diagnosis and after three months of treatment with tyrosine kinase inhibitor (TKI) .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All suspected patients for CML diagnosis aged more than 18 years who presented with high white blood cells(WBCs) count , marked shift to left in peripheral blood with or without splenomegaly .
Key inclusion criteria (1 listed)
- : All suspected patients for CML diagnosis aged more than 18 years who presented with high white blood cells(WBCs) count , marked shift to left in peripheral blood with or without splenomegaly .
Key exclusion criteria (1 listed)
- Patients on treatment or presence of blasts in peripheral blood sample.
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
Peripheral Blood Dipeptidylpeptidase IV (CD26)
Time frame: 1 year
to detect CD26+ LSCs by flow cytometry for accurate diagnosis of CML patients from peripheral blood sample to reduce the need for Bone Marrow aspiration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 19401558Lane SW, Scadden DT, Gilliland DG. The leukemic stem cell niche: current concepts and therapeutic opportunities. Blood. 2009 Aug 6;114(6):1150-7. doi: 10.1182/blood-2009-01-202606. Epub 2009 Apr 28.
- Background: PubMed 35602932Ebian HF, Abdelnabi AM, Abdelazem AS, Khamis T, Fawzy HM, Hussein S. Peripheral blood CD26 positive leukemic stem cells as a possible diagnostic and prognostic marker in chronic myeloid leukemia. Leuk Res Rep. 2022 May 9;17:100321. doi: 10.1016/j.lrr.2022.100321. eCollection 2022.
- Background: PubMed 26300881Waumans Y, Baerts L, Kehoe K, Lambeir AM, De Meester I. The Dipeptidyl Peptidase Family, Prolyl Oligopeptidase, and Prolyl Carboxypeptidase in the Immune System and Inflammatory Disease, Including Atherosclerosis. Front Immunol. 2015 Aug 7;6:387. doi: 10.3389/fimmu.2015.00387. eCollection 2015.
- Background: PubMed 23539735Lee SA, Kim YR, Yang EJ, Kwon EJ, Kim SH, Kang SH, Park DB, Oh BC, Kim J, Heo ST, Koh G, Lee DH. CD26/DPP4 levels in peripheral blood and T cells in patients with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Jun;98(6):2553-61. doi: 10.1210/jc.2012-4288. Epub 2013 Mar 28.
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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.
DR. Shaaban Helal, professor contact
Eid principal investigator
Sohag univerisity
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 Chronic Myeloid Leukemia, Chronic Phase, run by Sohag University at 1 site in Egypt.
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 16 Sep 2022. 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 Egypt. 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 Rowida Eid, Clinical Pathology Specialist (01002019899, rowaida-muhammad-post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Blood Dipeptidylpeptidase IV (CD26) (time frame: 1 year). 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 NCT05543161, which also lists 4 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 16 Sep 2022.