NeoplasmsNCT06369662
CD155 Expression in Acute Myeloid Leukemia
An observational study of Neoplasms and Hematologic Neoplasms, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neoplasms, Hematologic Neoplasms, Leukemia
- What is being tested?
- Flow cytometric immunophenotyping, Complete blood count and Bone marrow aspiration
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 31 May 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients (18 - 60 years old) diagnosed as AML
Who may be able to join
- 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.
Who cannot join
- Patients less than 18 years old and over 60 years.
- Patients with concurrent malignancy.
- Secondary AML.
- Acute Promyelocytic leukemia (AML-M3).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic and Predictive Values of CD155 in Patients With Acute Myeloid Leukemia
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.
Read the detailed description
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.
T-cell exhaustion is a state of decline in T-cell proliferation and function (secretion of cytokines and cytotoxicity). It is defined by the expression of immune checkpoints including programmed cell death protein-1 (PD1), cytotoxic T-lymphocyte-associated protein-4 (CTLA4), T-cell immunoglobulin and mucin-domain containing-3 (TIM3), lymphocyte-activation gene-3 (LAG3), T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT), and CD160. This phenomenon was observed in many cancer cells to escape from antitumor immune responses.
The poliovirus receptor (PVR), also known as CD155, is an immunoglobulin -like adhesion molecule, with an important regulatory role in T-cell and natural killer (NK) cell functions, cell migration and proliferation. It is a major ligand that is expressed on epithelial and myeloid cells of the tumor. PVR is able to bind CD226, DNAX accessory molecule-1 (DNAM-1), T-cell-Activated Increased Late Expression Protein (TACTILE), and TIGIT. Binding to DNAM-1 induces the release of pro-inflammatory cytokines and cytotoxicity of T-cells and NK cells (T-cell activation), while binding to TIGIT induces a rather anti-inflammatory, non-proliferative, and noncytotoxic profile (T-cell exhaustion).
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.
Stamm et al., demonstrated that high CD155 (PVR) expression correlated with poor outcome in AML. Stamm et al., also showed that antibody blockade of PVR on AML cell lines or primary AML cells or TIGIT blockade on immune cells increased the anti-leukemic effects mediated by purified CD3+ cells in vitro. Zhang et al., assessed the prognostic significance and immune-associated mechanism of CD155 and identified that CD155 was commonly upregulated in most human cancers including AML, and high expression of CD155 was closely correlated with unfavorable clinical outcomes.
Our aim is to study the prognostic and predictive values of CD155 expression in AML patients in our locality.
- Being tested
- Flow cytometric immunophenotyping, Complete blood count, Bone marrow aspiration, Cytogenetic testing, FLT3-ITD using High resolution melting curve (HRM) analysis
- Keywords
- CD155, AML, Survival
- Medical subject headings
- Neoplasms, Hematologic Neoplasms, Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometric immunophenotypingDiagnostic test
CD155 expression by flow cytometric immunophenotyping
Complete blood countDiagnostic test
Complete blood count with peripheral blood smear examination
Bone marrow aspirationDiagnostic test
Bone marrow aspiration at both diagnosis and follow up of patients
Cytogenetic testingDiagnostic test
Karyotyping or AML fluorescence in situ hybridization (FISH) panel for diagnosis and risk stratification of AML patients
FLT3-ITD using High resolution melting curve (HRM) analysisDiagnostic test
Detection of FLT3-ITD mutation in AML patinets
| Study group | Role | What they receive |
|---|---|---|
| AML Patients | Adult patients (from 18 - 60 years) diagnosed as AML Receives: Diagnostic Test: Flow cytometric immunophenotyping; Diagnostic Test: Complete blood count; Diagnostic Test: Bone marrow aspiration; Diagnostic Test: Cytogenetic testing; Diagnostic Test: FLT3-ITD using High resolution melting curve (HRM) analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD155 expression in AML
Study the CD155 expression by flow cytometry
Measured: 2 years
Secondary outcomes (2)
CD155 expression with patients' clinical data
Correlation of CD155 expression with clinical, hematological and cytogenetic data of AML patients
Measured: 2 years
CD155 expression and survival
Correlation of CD155 expression levels with patients' outcome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Adel Rayan Mohamed, Assiut University
- Investigators
- Nehal Rayan, M.D., Principal investigator, Assistant Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369662
- Sponsor's protocol ID
- SECI-CD155
- Other IDs
- SECI-IRB-IORG0006563-545
- Status last verified
- Oct 2024
- First submitted
- 12 Jul 2021
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28258695Gao 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.
PubMed 28730595Gorvel 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.
PubMed 32489646Li 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.
PubMed 29757192Liu 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.
PubMed 29477343Siegel 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.
PubMed 31912902Zhang 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.
PubMed 33576304Bakhshaei 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.
PubMed 29638208
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic and Predictive Values of CD155 in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06369662
- Acronym / sponsor ID
- SECI-CD155
- Keywords
- CD155, AML, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 17 Apr 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.
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.
Detailed description
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.
T-cell exhaustion is a state of decline in T-cell proliferation and function (secretion of cytokines and cytotoxicity). It is defined by the expression of immune checkpoints including programmed cell death protein-1 (PD1), cytotoxic T-lymphocyte-associated protein-4 (CTLA4), T-cell immunoglobulin and mucin-domain containing-3 (TIM3), lymphocyte-activation gene-3 (LAG3), T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT), and CD160. This phenomenon was observed in many cancer cells to escape from antitumor immune responses.
The poliovirus receptor (PVR), also known as CD155, is an immunoglobulin -like adhesion molecule, with an important regulatory role in T-cell and natural killer (NK) cell functions, cell migration and proliferation. It is a major ligand that is expressed on epithelial and myeloid cells of the tumor. PVR is able to bind CD226, DNAX accessory molecule-1 (DNAM-1), T-cell-Activated Increased Late Expression Protein (TACTILE), and TIGIT. Binding to DNAM-1 induces the release of pro-inflammatory cytokines and cytotoxicity of T-cells and NK cells (T-cell activation), while binding to TIGIT induces a rather anti-inflammatory, non-proliferative, and noncytotoxic profile (T-cell exhaustion).
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.
Stamm et al., demonstrated that high CD155 (PVR) expression correlated with poor outcome in AML. Stamm et al., also showed that antibody blockade of PVR on AML cell lines or primary AML cells or TIGIT blockade on immune cells increased the anti-leukemic effects mediated by purified CD3+ cells in vitro. Zhang et al., assessed the prognostic significance and immune-associated mechanism of CD155 and identified that CD155 was commonly upregulated in most human cancers including AML, and high expression of CD155 was closely correlated with unfavorable clinical outcomes.
Our aim is to study the prognostic and predictive values of CD155 expression in AML patients in our locality.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML Patients | – | Diagnostic Test: Flow cytometric immunophenotyping, Diagnostic Test: Complete blood count, Diagnostic Test: Bone marrow aspiration, Diagnostic Test: Cytogenetic testing, Diagnostic Test: FLT3-ITD using High resolution melting curve (HRM) analysisAdult patients (from 18 - 60 years) diagnosed as AML |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients (18 - 60 years old) diagnosed as AML
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients less than 18 years old and over 60 years.
- Patients with concurrent malignancy.
- Secondary AML.
- Acute Promyelocytic leukemia (AML-M3).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow cytometric immunophenotypingCD155 expression by flow cytometric immunophenotyping | Diagnostic test | AML Patients |
| Complete blood countComplete blood count with peripheral blood smear examination | Diagnostic test | AML Patients |
| Bone marrow aspirationBone marrow aspiration at both diagnosis and follow up of patients | Diagnostic test | AML Patients |
| Cytogenetic testingKaryotyping or AML fluorescence in situ hybridization (FISH) panel for diagnosis and risk stratification of AML patients | Diagnostic test | AML Patients |
| FLT3-ITD using High resolution melting curve (HRM) analysisDetection of FLT3-ITD mutation in AML patinets | Diagnostic test | AML Patients |
Primary outcome
CD155 expression in AML
Time frame: 2 years
Study the CD155 expression by flow cytometry
2 secondary outcomes
CD155 expression with patients' clinical data
Time frame: 2 years
CD155 expression and survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 28258695Dougall 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.
- Background: PubMed 28730595Gao 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.
- Background: PubMed 32489646Gorvel 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.
- Background: PubMed 29757192Li 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.
- Background: PubMed 29477343Liu 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.
- Background: PubMed 31912902Siegel 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.
- Background: PubMed 33576304Zhang 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.
- Results publication: PubMed 29638208Bakhshaei 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nehal Rayan, M.D. principal investigator
Assistant Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Hematologic Neoplasms, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD155 expression in AML (time frame: 2 years). 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 NCT06369662, which also lists 8 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 16 Oct 2024.