Chronic Myeloid Leukemia in RemissionNCT06266975
Chronic Kidney Disease Patient in Chronic Myloied Leukemia
An observational study of Chronic Myeloid Leukemia in Remission, run by Sahar Mohammed Gad.
Trial summary
To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Myeloid Leukemia in Remission
- What is being tested?
- Biobsy from kidney
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: all sexes , adult , not diabetic , not known CKD before diagnosed of CML
Inclusion Criteria:1_ Chronic myloid leukemia patiants who diagonised by biopsy , 2_ CBC.
-
Exclusion : 1_pts known to have CKD before diagnosed of CML. 2- known Diabetic pts 3-imaging suggestive CKD etiology rather than CML effect eg.PKD,renal stones,chronic pyelonephritis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia .
Read the detailed description
- Chronic myeloid leukemia (CML) is a cancer of bone marrow that leads to an increased number of white blood cells. CML is more prevalent in the elderly and is characterized by weight loss, tiredness, shortness of breath, excessive sweating, bone pain, and frequent infections. [1] According to the American Cancer Society's estimates, CML represents 15% of all new leukemia cases.[2] The global burden of disease (GBD) study 2015 revealed that leukemia was under the top ten leading causes of death globally.[3] However, the latest GBD study found a decrease in the age-standardized incidence rate and the death rate from 1990-2017.[4] This dramatic improvement in the overall survival and health-related quality of life among CML patients was attributed to the impact of new therapeutic strategies. Tyrosine kinase inhibitors (TKIs), particularly imatinib, emerged as a potential therapeutic agent for the treatment of CML, reducing epidemiological burden (incidence rate), and improve quality of life.[5]
- The definition and classification of chronic kidney disease (CKD) have evolved over time, but current international guidelines define this condition as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1•73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause[6] Diagnosis is commonly made after chance findings from screening tests (urinary dipstick or blood tests), or when symptoms become severe. The best available indicator of overall kidney function is GFR, which is measured either via exogenous markers (eg, DTPA, iohexol), or estimated using equations. Presence of proteinuria is associated with increased risk of progression of CKD and death. Presence of proteinuria is associated with increased risk of progression of CKD and death.[7,8] Kidney biopsy samples can show definitive evidence of CKD, through common changes such as glomerular sclerosis, tubular atrophy, and interstitial fibrosis. Complications include anaemia due to reduced production of erythropoietin by the kidney; reduced red blood cell survival and iron deficiency; and mineral bone disease caused by disturbed vitamin D, calcium, and phosphate metabolism.[9
- Conditions
- Chronic Myeloid Leukemia in Remission
- Being tested
- Biobsy from kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobsy from kidneyDevice
Also called drug , tyrosine kinase inhibitors particulary imatinib in ttt CML patients
using tyrosine kinase inhibitors particulary imatinib in ttt CML patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Kidney Disease Patient in Chronic Myloied Leukemia
Using Non Invasive or invasive Methods and correlation between lab and radiological methods to find and a relation between CML and CKD and outcome.
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid Leukemia in RemissionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahar Mohammed Gad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahar Mohammed Gad, Assiut University
- Investigators
- Ahmed Ramadan, Principal investigator, AssistMohamed Ramadan, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266975
- Sponsor's protocol ID
- CKD pts in CML
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
PubMed 27887750Fathallah-Shaykh SA, Flynn JT, Pierce CB, Abraham AG, Blydt-Hansen TD, Massengill SF, Moxey-Mims MM, Warady BA, Furth SL, Wong CS. Progression of pediatric CKD of nonglomerular origin in the CKiD cohort. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):571-7. doi: 10.2215/CJN.07480714. Epub 2015 Jan 29.
PubMed 25635034
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease Patient in Chronic Myloied Leukemia
- ClinicalTrials.gov ID
- NCT06266975
- Acronym / sponsor ID
- CKD pts in CML
- Conditions
- Chronic Myeloid Leukemia in Remission
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sahar Mohammed GadUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Feb 2024 (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.
To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia .
Detailed description
- Chronic myeloid leukemia (CML) is a cancer of bone marrow that leads to an increased number of white blood cells. CML is more prevalent in the elderly and is characterized by weight loss, tiredness, shortness of breath, excessive sweating, bone pain, and frequent infections. [1] According to the American Cancer Society's estimates, CML represents 15% of all new leukemia cases.[2] The global burden of disease (GBD) study 2015 revealed that leukemia was under the top ten leading causes of death globally.[3] However, the latest GBD study found a decrease in the age-standardized incidence rate and the death rate from 1990-2017.[4] This dramatic improvement in the overall survival and health-related quality of life among CML patients was attributed to the impact of new therapeutic strategies. Tyrosine kinase inhibitors (TKIs), particularly imatinib, emerged as a potential therapeutic agent for the treatment of CML, reducing epidemiological burden (incidence rate), and improve quality of life.[5]
- The definition and classification of chronic kidney disease (CKD) have evolved over time, but current international guidelines define this condition as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1•73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause[6] Diagnosis is commonly made after chance findings from screening tests (urinary dipstick or blood tests), or when symptoms become severe. The best available indicator of overall kidney function is GFR, which is measured either via exogenous markers (eg, DTPA, iohexol), or estimated using equations. Presence of proteinuria is associated with increased risk of progression of CKD and death. Presence of proteinuria is associated with increased risk of progression of CKD and death.[7,8] Kidney biopsy samples can show definitive evidence of CKD, through common changes such as glomerular sclerosis, tubular atrophy, and interstitial fibrosis. Complications include anaemia due to reduced production of erythropoietin by the kidney; reduced red blood cell survival and iron deficiency; and mineral bone disease caused by disturbed vitamin D, calcium, and phosphate metabolism.[9
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all sexes , adult , not diabetic , not known CKD before diagnosed of CML
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 |
|---|---|---|
| Biobsy from kidneyAlso: drug , tyrosine kinase inhibitors particulary imatinib in ttt CML patientsusing tyrosine kinase inhibitors particulary imatinib in ttt CML patients | Device | – |
Primary outcome
Chronic Kidney Disease Patient in Chronic Myloied Leukemia
Time frame: basline
Using Non Invasive or invasive Methods and correlation between lab and radiological methods to find and a relation between CML and CKD and outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 27887750Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
- Background: PubMed 25635034Fathallah-Shaykh SA, Flynn JT, Pierce CB, Abraham AG, Blydt-Hansen TD, Massengill SF, Moxey-Mims MM, Warady BA, Furth SL, Wong CS. Progression of pediatric CKD of nonglomerular origin in the CKiD cohort. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):571-7. doi: 10.2215/CJN.07480714. Epub 2015 Jan 29.
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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.
Ahmed Ramadan principal investigator
Assist
Mohamed Ramadan study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia in Remission, run by Sahar Mohammed Gad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 20 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sahar mohamed gad, third (01007531866, sahargad22397@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Kidney Disease Patient in Chronic Myloied Leukemia (time frame: basline). 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 NCT06266975, which also lists 2 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 20 Feb 2024.