NCT06674850

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

October 27, 2024

Last Update Submit

November 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Secondary Outcomes (1)

  • Assessment of systemic inflammatory index (SII) as a biomarker for acute lymphoblastic leukemia prognosis

    one year

Study Arms (2)

Diseased group

36 patients with acute lymphoblastic leukemia will be included

Control group

36 healthy people will be included

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.

You may qualify if:

  • Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.

You may not qualify if:

  • Presence of other hematological disorders( other than ALL)
  • History of other malignancies, or relapsed ALL.
  • Patients under chemotherapy or radiotherapy. 3- Signs of inflammation 5- Evidence of autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • Tang 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.

  • Roberts 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.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Asmaa zhran

    Assiut University

    STUDY CHAIR
  • Doaa Temeric

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 27, 2024

First Posted

November 5, 2024

Study Start

November 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11