Acute Lymphoblastic LeukemiaNCT06674850
Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by Assiut University.
Trial summary
the goal of this observational study is Assesment of systemic inflammatory index (SII) , system inflammation response index (SIRI) and CRP Albumin ratio(CAR) as biomarkers for ALL prognosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.
Who may be able to join
- Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.
Who cannot join
- Presence of other hematological disorders( other than ALL)
- History of other malignancies, or relapsed ALL.
- 2- Patients under chemotherapy or radiotherapy. 3- Signs of inflammation 5- Evidence of autoimmune disease.
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
Official title: Assessment of the Prognostic Role of Systemic Inflammatory Index, Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia
the goal of this observational study is Assesment of systemic inflammatory index (SII) , system inflammation response index (SIRI) and CRP Albumin ratio(CAR) as biomarkers for ALL prognosis.
Read the detailed description
Acute lymphoblastic leukemia (ALL) results from a clonal expansion of abnormal, immature lymphoid progenitors of B cell or T cell origin that invade bone marrow (BM), peripheral blood, and extramedullary sites .
The incidence of ALL is highest among children aged 1-4 years and declines with age rising slightly after the age of 50. Several genetic alterations have been already found as drivers of ALL, uncovering the genetic heterogeneity of the disease.
It is the most common leukemia in the pediatric population, according for up to 80% of cases in this group vs. 20% of cases in adults. Treatment among adolscents and young adults is predominantly inspired by pediatric regimens with better survival rates .
Acute leukemia tends to present non-specifically, although the most common presenting features include fever, lethargy, and bleeding. Hepatosplenomegaly, lymphadenopathy, and musculoskeletal symptoms (especially involving the spine and long bones) can also be clues to the diagnosis. Adults may also have more prominent anemia-related symptoms, such as shortness of breath, or symptoms related to thrombocytopenia, such as excessive bruising or increased bleeding tendency.
- Conditions
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diseased group | 36 patients with acute lymphoblastic leukemia will be included | |
| Control group | 36 healthy people will be included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis
Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis
Measured: one year
Secondary outcomes (1)
Assessment of systemic inflammatory index (SII) as a biomarker for acute lymphoblastic leukemia prognosis
Assessment of systemic inflammatory index (SII) as a biomarker for acute lymphoblastic leukemia prognosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Hamoda Ahmed, Assiut University
- Investigators
- Asmaa zhran, Study chair, Assiut UniversityDoaa Temeric, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674850
- Sponsor's protocol ID
- inflammation in leukemia
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
di Masi A. Human Serum Albumin: From Molecular Aspects to Biotechnological Applications. Int J Mol Sci. 2023 Feb 17;24(4):4081. doi: 10.3390/ijms24044081.
PubMed 36835490Tang HN, Pan BH, Wang L, Zhu HY, Fan L, Xu W, Li JY. C-reactive protein-to-albumin ratio is an independent poor prognostic factor in newly diagnosed chronic lymphocytic leukaemia: A clinical analysis of 322 cases. Transl Oncol. 2021 Apr;14(4):101035. doi: 10.1016/j.tranon.2021.101035. Epub 2021 Feb 11.
PubMed 33582571Roberts KG, Mullighan CG. The Biology of B-Progenitor Acute Lymphoblastic Leukemia. Cold Spring Harb Perspect Med. 2020 Jul 1;10(7):a034835. doi: 10.1101/cshperspect.a034835.
PubMed 31653664
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prognostic Role of Systemic Inflammatory Index, Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06674850
- Acronym / sponsor ID
- inflammation in leukemia
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 5 Nov 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.
the goal of this observational study is Assesment of systemic inflammatory index (SII) , system inflammation response index (SIRI) and CRP Albumin ratio(CAR) as biomarkers for ALL prognosis.
Detailed description
Acute lymphoblastic leukemia (ALL) results from a clonal expansion of abnormal, immature lymphoid progenitors of B cell or T cell origin that invade bone marrow (BM), peripheral blood, and extramedullary sites .
The incidence of ALL is highest among children aged 1-4 years and declines with age rising slightly after the age of 50. Several genetic alterations have been already found as drivers of ALL, uncovering the genetic heterogeneity of the disease.
It is the most common leukemia in the pediatric population, according for up to 80% of cases in this group vs. 20% of cases in adults. Treatment among adolscents and young adults is predominantly inspired by pediatric regimens with better survival rates .
Acute leukemia tends to present non-specifically, although the most common presenting features include fever, lethargy, and bleeding. Hepatosplenomegaly, lymphadenopathy, and musculoskeletal symptoms (especially involving the spine and long bones) can also be clues to the diagnosis. Adults may also have more prominent anemia-related symptoms, such as shortness of breath, or symptoms related to thrombocytopenia, such as excessive bruising or increased bleeding tendency.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diseased group | – | –36 patients with acute lymphoblastic leukemia will be included |
| Control group | – | –36 healthy people will be included |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.
Key inclusion criteria (1 listed)
- Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.
Key exclusion criteria (3 listed)
- Presence of other hematological disorders( other than ALL)
- History of other malignancies, or relapsed ALL.
- 2- Patients under chemotherapy or radiotherapy. 3- Signs of inflammation 5- Evidence of autoimmune disease.
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
Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis
Time frame: one year
Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis
1 secondary outcome
Assessment of systemic inflammatory index (SII) as a biomarker for acute lymphoblastic leukemia prognosis
Time frame: one year
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 5 Nov 2024.
- Results publication: PubMed 36835490di Masi A. Human Serum Albumin: From Molecular Aspects to Biotechnological Applications. Int J Mol Sci. 2023 Feb 17;24(4):4081. doi: 10.3390/ijms24044081.
- Results publication: PubMed 33582571Tang HN, Pan BH, Wang L, Zhu HY, Fan L, Xu W, Li JY. C-reactive protein-to-albumin ratio is an independent poor prognostic factor in newly diagnosed chronic lymphocytic leukaemia: A clinical analysis of 322 cases. Transl Oncol. 2021 Apr;14(4):101035. doi: 10.1016/j.tranon.2021.101035. Epub 2021 Feb 11.
- Results publication: PubMed 31653664Roberts KG, Mullighan CG. The Biology of B-Progenitor Acute Lymphoblastic Leukemia. Cold Spring Harb Perspect Med. 2020 Jul 1;10(7):a034835. doi: 10.1101/cshperspect.a034835.
- Individual participant dataSharing planned: Undecided
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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.
Asmaa zhran study chair
Assiut University
Doaa Temeric study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, 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: opening soon, as of the sponsor's last update on 5 Nov 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 Esraa Hamoda (+2001066177369, esraahamoda73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis (time frame: one 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 NCT06674850, which also lists 3 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 5 Nov 2024.