Prognostic Value of CD318 in AML at Assiut University Hospital.

Sponsor
Shimaa Arafa Ibrahim (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04708444
Collaborator
(none)
100
24

Study Details

Study Description

Brief Summary

We will focus on the prognostic value of CD318 in acute myeloid leukemia patients at Assiut University Hospital

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CD318

Detailed Description

Acute myeloid leukemia (AML) is a disease with high mortality and variable prognosis . It remains a disease with a highly variable outcome depending on the exact footprint of the AML .Although many patients with AML have a response to induction therapy ,refractory disease is common and relapse represents the major cause of treatment failure .In 2016 the World Heath Organization published revisions to classification of Myeloid Neoplasms and Acute leukemias .Well-established prognostic factors are cytogenetic aberrations such as t(8;21), inv(16), and t(15;17) as well as mutated IDH1/2, NPM1, and FLT3 genes but only few markers can specifically predict the outcome after HSCT .Immunophenotyping via flowcytometry comprises an additional fast technique to predict outcome in AML, although only few markers are yet established as prognostic factors in clinical routine diagnosis, despite the fact that new and rapidly available markers are needed to improve the treatment decisions in AML patients. This is even more since starting therapy in AML patients must be initiated immediately after diagnosis . Overall mortality from AML is high and treatment should be initiated within hours after first diagnosis . In hematopoietic cells,CD318 has been identified as stem cell marker for both benign and malignant progenitor cells. CD318+ bone marrow or cord blood-derived cells have been shown to be capable to initiate multi-lineage hematopoiesis in vitro and in vivo .CD318 (CUB domain containing protein-1, CDCP1) is a highly glycosylated single pass transmembrane protein express endomesenchymal and neural stem cells and fibroblasts and hematopoietic.Overexpression of CD318 has been recently correlated with poor overall survival(OS) in colonic ,breast ,renal, hepatocellular ,and pancreatic Carcinoma.possibly due to its role in metastasis formation via interaction with integrins and anti-apoptotic signaling via Akt. Of AML blasts, pronounced CD318 expression has been observed on the immature CD34+CD133+ leukemic cells subset implicated to be enriched for leukemic stem. However, the impact of CD318 on survival in hematological malignancies has so far not been analyzed. Study done by Jonas S et al showed 57% of AML patients expressed relevant CD318 levels and a significant correlation of CD 318 surface levels with prognosis was observed . In our study investigators will use flowcytometry to detect CD318 on AML blasts and correlate it with disease course and outcome.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prognostic Value of CD318 in Acute Myeloid Leukemia Patients at Assiut University Hospital
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Prognosis of CD318 in AML [Throughout study completion, average of one year]

    Flowcytometric analysis of AML blasts for CD318 and correlate it with disease course (progression free survival) and disease outcome (overall survival) . Also correlate level of expression of CD318 with response to treatment given ( intensive chemotherapy, hypomethylating agents, alternative palliative therapy. CD318 to detect level of expression and correlate it with disease course (progression free survival) and outcome (overall survival) .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. newly diagnosed AML patients

  2. Age more than 18 years

  3. Patients not starting chemotherapy yet

  4. Primary AML

  5. Secondary AML on top of MDS or myeloproliverative noeplasms

Exclusion Criteria:
  1. Refractory AML patients

  2. Relapsed AML patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shimaa Arafa Ibrahim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shimaa Arafa Ibrahim, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT04708444
Other Study ID Numbers:
  • CD318 in AML
First Posted:
Jan 14, 2021
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2021