Liver Toxicity, Chemically-InducedNCT06383325
Livertoxcicity in Acute Leukemia Patients During Chemotherapy Treatment
An observational study of Liver Toxicity, Chemically-Induced, run by Assiut University.
Trial summary
Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Toxicity, Chemically-Induced
- What is being tested?
- Chemotherapy
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Aug 2025
- 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
- Adult, Older adult
Study population: Participants who will be diagnosed as acute leukemia and going to receive chemotherapy after
Who may be able to join
- patients newly diagnosed with acute leukemia who are going to start chemotherapy treatment
Who cannot join
- patients previously diagnosed Acute leukemia and started treatment or in post treatment follow up
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Liver Function Test to Identify Hepatotoxcicity Among Acute Leukemia Patients Who Are Receiving Chemotherapy Induction
Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt
Read the detailed description
Chemotherapy induction associated with hepatotoxicity during the induction has never been studied the study aimed to determine whether chemotherapy induction is associated with livertoxicity or not
- Conditions
- Liver Toxicity, Chemically-Induced
- Being tested
- Chemotherapy
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyCombination product
Detection of hepatotoxicity in acute leukemia patients during chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment
Evaluation of liver function test to identfy hepatotoxicity during chemotherapy treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Toxicity, Chemically-InducedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Hohamed Hamada Wahba, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383325
- Sponsor's protocol ID
- Livertoxcicity in AL
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mekonnen AT, Wondmeneh TG. Evaluation of liver function tests to identify hepatotoxicity among acute lymphoblastic leukemia patients who are receiving chemotherapy induction. Sci Rep. 2022 Aug 2;12(1):13215. doi: 10.1038/s41598-022-17618-w.
PubMed 35918381
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Function Test to Identify Hepatotoxcicity Among Acute Leukemia Patients Who Are Receiving Chemotherapy Induction
- ClinicalTrials.gov ID
- NCT06383325
- Acronym / sponsor ID
- Livertoxcicity in AL
- Conditions
- Liver Toxicity, Chemically-Induced
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 25 Apr 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.
Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt
Detailed description
Chemotherapy induction associated with hepatotoxicity during the induction has never been studied the study aimed to determine whether chemotherapy induction is associated with livertoxicity or not
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants who will be diagnosed as acute leukemia and going to receive chemotherapy after
Key inclusion criteria (1 listed)
- patients newly diagnosed with acute leukemia who are going to start chemotherapy treatment
Key exclusion criteria (1 listed)
- patients previously diagnosed Acute leukemia and started treatment or in post treatment follow up
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 |
|---|---|---|
| ChemotherapyDetection of hepatotoxicity in acute leukemia patients during chemotherapy | Combination product | – |
Primary outcome
Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment
Time frame: 3 months
Evaluation of liver function test to identfy hepatotoxicity during chemotherapy treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 35918381Mekonnen AT, Wondmeneh TG. Evaluation of liver function tests to identify hepatotoxicity among acute lymphoblastic leukemia patients who are receiving chemotherapy induction. Sci Rep. 2022 Aug 2;12(1):13215. doi: 10.1038/s41598-022-17618-w.
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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 Liver Toxicity, Chemically-Induced, 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 25 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada mohamed hamada Hamada wahba (01140476425, Nm3390103@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment (time frame: 3 months). 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 NCT06383325, which also lists 1 linked publication.
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 25 Apr 2024.