NCT06369662

Brief Summary

Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy. It is the most common form of acute leukemia among adults. In the United States, an estimated 19,940 people will be diagnosed with AML in 2020. CD155 expression was associated with an unfavorable prognosis in solid tumors such as colon cancer, breast cancer, lung adenocarcinoma, pancreatic cancer, melanoma, and glioblastoma, as it correlated with tumor migration, development of metastases, tissue and lymph node invasion, relapse, and poorer survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

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

July 12, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

July 12, 2021

Last Update Submit

October 12, 2024

Conditions

Keywords

CD155AMLSurvival

Outcome Measures

Primary Outcomes (1)

  • CD155 expression in AML

    Study the CD155 expression by flow cytometry

    2 years

Secondary Outcomes (2)

  • CD155 expression with patients' clinical data

    2 years

  • CD155 expression and survival

    2 years

Study Arms (1)

AML Patients

Adult patients (from 18 - 60 years) diagnosed as AML

Diagnostic Test: Flow cytometric immunophenotypingDiagnostic Test: Complete blood countDiagnostic Test: Bone marrow aspirationDiagnostic Test: Cytogenetic testingDiagnostic Test: FLT3-ITD using High resolution melting curve (HRM) analysis

Interventions

CD155 expression by flow cytometric immunophenotyping

AML Patients
Complete blood countDIAGNOSTIC_TEST

Complete blood count with peripheral blood smear examination

AML Patients
Bone marrow aspirationDIAGNOSTIC_TEST

Bone marrow aspiration at both diagnosis and follow up of patients

AML Patients
Cytogenetic testingDIAGNOSTIC_TEST

Karyotyping or AML fluorescence in situ hybridization (FISH) panel for diagnosis and risk stratification of AML patients

AML Patients

Detection of FLT3-ITD mutation in AML patinets

AML Patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients (18 - 60 years old) diagnosed as AML

You may qualify if:

  • Patients with newly diagnosed AML.
  • Age group: patients more than 18 years old and less than 60 years.
  • Patients receiving induction chemotherapy 3\&7 at South Egypt Cancer Institute.

You may not qualify if:

  • Patients less than 18 years old and over 60 years.
  • Patients with concurrent malignancy.
  • Secondary AML.
  • Acute Promyelocytic leukemia (AML-M3).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Institute, Assiut University

Asyut, 71111, Egypt

Location

Related Publications (8)

  • Dougall WC, Kurtulus S, Smyth MJ, Anderson AC. TIGIT and CD96: new checkpoint receptor targets for cancer immunotherapy. Immunol Rev. 2017 Mar;276(1):112-120. doi: 10.1111/imr.12518.

    PMID: 28258695BACKGROUND
  • Gao J, Zheng Q, Xin N, Wang W, Zhao C. CD155, an onco-immunologic molecule in human tumors. Cancer Sci. 2017 Oct;108(10):1934-1938. doi: 10.1111/cas.13324. Epub 2017 Aug 18.

    PMID: 28730595BACKGROUND
  • Gorvel L, Olive D. Targeting the "PVR-TIGIT axis" with immune checkpoint therapies. F1000Res. 2020 May 13;9:F1000 Faculty Rev-354. doi: 10.12688/f1000research.22877.1. eCollection 2020.

    PMID: 32489646BACKGROUND
  • Li XY, Das I, Lepletier A, Addala V, Bald T, Stannard K, Barkauskas D, Liu J, Aguilera AR, Takeda K, Braun M, Nakamura K, Jacquelin S, Lane SW, Teng MW, Dougall WC, Smyth MJ. CD155 loss enhances tumor suppression via combined host and tumor-intrinsic mechanisms. J Clin Invest. 2018 Jun 1;128(6):2613-2625. doi: 10.1172/JCI98769. Epub 2018 May 14.

    PMID: 29757192BACKGROUND
  • Liu L, Chang YJ, Xu LP, Zhang XH, Wang Y, Liu KY, Huang XJ. T cell exhaustion characterized by compromised MHC class I and II restricted cytotoxic activity associates with acute B lymphoblastic leukemia relapse after allogeneic hematopoietic stem cell transplantation. Clin Immunol. 2018 May;190:32-40. doi: 10.1016/j.clim.2018.02.009. Epub 2018 Mar 15.

    PMID: 29477343BACKGROUND
  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PMID: 31912902BACKGROUND
  • Zhang H, Yang Z, Du G, Cao L, Tan B. CD155-Prognostic and Immunotherapeutic Implications Based on Multiple Analyses of Databases Across 33 Human Cancers. Technol Cancer Res Treat. 2021 Jan-Dec;20:1533033820980088. doi: 10.1177/1533033820980088.

    PMID: 33576304BACKGROUND
  • Bakhshaei P, Kazemi MH, Golara M, Abdolmaleki S, Khosravi-Eghbal R, Khoshnoodi J, Judaki MA, Salimi V, Douraghi M, Jeddi-Tehrani M, Shokri F. Investigation of the Cellular Immune Response to Recombinant Fragments of Filamentous Hemagglutinin and Pertactin of Bordetella pertussis in BALB/c Mice. J Interferon Cytokine Res. 2018 Apr;38(4):161-170. doi: 10.1089/jir.2017.0060.

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood or Bone marrow aspiration specimens

MeSH Terms

Conditions

NeoplasmsHematologic NeoplasmsLeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Nehal Rayan, M.D.

    Assistant Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 12, 2021

First Posted

April 17, 2024

Study Start

July 1, 2022

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations