Prognostic Value of CD318 in AML at Assiut University Hospital.

January 17, 2021 updated by: Shimaa Arafa Ibrahim

Prognostic Value of CD318 in Acute Myeloid Leukemia Patients at Assiut University Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

our study will include newly diagnosed AML patients at clinical hematology unit Assiut University during the period from March 2021 to August 2022. The diagnosis and classification of AML relied on morphology and cytochemistry of bone marrow according to FAB classification. patients will be subjected to full history taking clinical examination laboratory investigations CBC,LFTs,RFTs,electrolytes,ESR,LDH,CRP,Coagulationprofile,aptt ,fibrinogen, D dimer, bone marrow assessment with immunephenotyping and cytogenetic analysis.

Flowcytometric analysis of AML blasts for CD 318

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognosis of CD318 in AML
Time Frame: 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) .
Throughout study completion, average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shimaa Arafa Ibrahim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD318 in AML

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe