NCT04708444

Brief Summary

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

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Status
unknown

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

January 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

January 8, 2021

Last Update Submit

January 17, 2021

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Prognosis of CD318 in AML

    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

Interventions

CD318DIAGNOSTIC_TEST

Flowcytometric marker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • newly diagnosed AML patients
  • Age more than 18 years
  • Patients not starting chemotherapy yet
  • Primary AML
  • Secondary AML on top of MDS or myeloproliverative noeplasms

You may not qualify if:

  • Refractory AML patients
  • Relapsed AML patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Grimwade D, Walker H, Oliver F, Wheatley K, Harrison C, Harrison G, Rees J, Hann I, Stevens R, Burnett A, Goldstone A. The importance of diagnostic cytogenetics on outcome in AML: analysis of 1,612 patients entered into the MRC AML 10 trial. The Medical Research Council Adult and Children's Leukaemia Working Parties. Blood. 1998 Oct 1;92(7):2322-33.

    PMID: 9746770BACKGROUND

  • Grimwade D, Walker H, Harrison G, Oliver F, Chatters S, Harrison CJ, Wheatley K, Burnett AK, Goldstone AH; Medical Research Council Adult Leukemia Working Party. The predictive value of hierarchical cytogenetic classification in older adults with acute myeloid leukemia (AML): analysis of 1065 patients entered into the United Kingdom Medical Research Council AML11 trial. Blood. 2001 Sep 1;98(5):1312-20. doi: 10.1182/blood.v98.5.1312.

    PMID: 11520776BACKGROUND

  • Kottaridis PD, Gale RE, Frew ME, Harrison G, Langabeer SE, Belton AA, Walker H, Wheatley K, Bowen DT, Burnett AK, Goldstone AH, Linch DC. The presence of a FLT3 internal tandem duplication in patients with acute myeloid leukemia (AML) adds important prognostic information to cytogenetic risk group and response to the first cycle of chemotherapy: analysis of 854 patients from the United Kingdom Medical Research Council AML 10 and 12 trials. Blood. 2001 Sep 15;98(6):1752-9. doi: 10.1182/blood.v98.6.1752.

    PMID: 11535508BACKGROUND

  • Conze T, Lammers R, Kuci S, Scherl-Mostageer M, Schweifer N, Kanz L, Buhring HJ. CDCP1 is a novel marker for hematopoietic stem cells. Ann N Y Acad Sci. 2003 May;996:222-6. doi: 10.1111/j.1749-6632.2003.tb03249.x.

    PMID: 12799299BACKGROUND

  • Scherl-Mostageer M, Sommergruber W, Abseher R, Hauptmann R, Ambros P, Schweifer N. Identification of a novel gene, CDCP1, overexpressed in human colorectal cancer. Oncogene. 2001 Jul 19;20(32):4402-8. doi: 10.1038/sj.onc.1204566.

    PMID: 11466621BACKGROUND

  • Hooper JD, Zijlstra A, Aimes RT, Liang H, Claassen GF, Tarin D, Testa JE, Quigley JP. Subtractive immunization using highly metastatic human tumor cells identifies SIMA135/CDCP1, a 135 kDa cell surface phosphorylated glycoprotein antigen. Oncogene. 2003 Mar 27;22(12):1783-94. doi: 10.1038/sj.onc.1206220.

    PMID: 12660814BACKGROUND

  • Casar B, Rimann I, Kato H, Shattil SJ, Quigley JP, Deryugina EI. In vivo cleaved CDCP1 promotes early tumor dissemination via complexing with activated beta1 integrin and induction of FAK/PI3K/Akt motility signaling. Oncogene. 2014 Jan 9;33(2):255-68. doi: 10.1038/onc.2012.547. Epub 2012 Dec 3.

    PMID: 23208492BACKGROUND

  • Liersch R, Muller-Tidow C, Berdel WE, Krug U. Prognostic factors for acute myeloid leukaemia in adults--biological significance and clinical use. Br J Haematol. 2014 Apr;165(1):17-38. doi: 10.1111/bjh.12750. Epub 2014 Feb 1.

    PMID: 24484469BACKGROUND

  • Uekita T, Fujii S, Miyazawa Y, Iwakawa R, Narisawa-Saito M, Nakashima K, Tsuta K, Tsuda H, Kiyono T, Yokota J, Sakai R. Oncogenic Ras/ERK signaling activates CDCP1 to promote tumor invasion and metastasis. Mol Cancer Res. 2014 Oct;12(10):1449-59. doi: 10.1158/1541-7786.MCR-13-0587. Epub 2014 Jun 17.

    PMID: 24939643BACKGROUND

  • Alajati A, Guccini I, Pinton S, Garcia-Escudero R, Bernasocchi T, Sarti M, Montani E, Rinaldi A, Montemurro F, Catapano C, Bertoni F, Alimonti A. Interaction of CDCP1 with HER2 enhances HER2-driven tumorigenesis and promotes trastuzumab resistance in breast cancer. Cell Rep. 2015 Apr 28;11(4):564-76. doi: 10.1016/j.celrep.2015.03.044. Epub 2015 Apr 16.

    PMID: 25892239BACKGROUND

  • Dohner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015 Sep 17;373(12):1136-52. doi: 10.1056/NEJMra1406184. No abstract available.

    PMID: 26376137BACKGROUND

  • Schmid C, Labopin M, Socie G, Daguindau E, Volin L, Huynh A, Bourhis JH, Milpied N, Cornelissen J, Chevallier P, Maertens J, Jindra P, Blaise D, Lenhoff S, Ifrah N, Baron F, Ciceri F, Gorin C, Savani B, Giebel S, Polge E, Esteve J, Nagler A, Mohty M; Acute Leukemia Working Party of the European Group of Blood and Bone Marrow Transplantation. Outcome of patients with distinct molecular genotypes and cytogenetically normal AML after allogeneic transplantation. Blood. 2015 Oct 22;126(17):2062-9. doi: 10.1182/blood-2015-06-651562. Epub 2015 Sep 8.

    PMID: 26351297BACKGROUND

  • Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.

    PMID: 27069254BACKGROUND

  • De Kouchkovsky I, Abdul-Hay M. 'Acute myeloid leukemia: a comprehensive review and 2016 update'. Blood Cancer J. 2016 Jul 1;6(7):e441. doi: 10.1038/bcj.2016.50.

    PMID: 27367478BACKGROUND

  • Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, Dombret H, Ebert BL, Fenaux P, Larson RA, Levine RL, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz M, Sierra J, Tallman MS, Tien HF, Wei AH, Lowenberg B, Bloomfield CD. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196. Epub 2016 Nov 28.

    PMID: 27895058BACKGROUND

  • Enyindah-Asonye G, Li Y, Ruth JH, Spassov DS, Hebron KE, Zijlstra A, Moasser MM, Wang B, Singer NG, Cui H, Ohara RA, Rasmussen SM, Fox DA, Lin F. CD318 is a ligand for CD6. Proc Natl Acad Sci U S A. 2017 Aug 15;114(33):E6912-E6921. doi: 10.1073/pnas.1704008114. Epub 2017 Jul 31.

    PMID: 28760953BACKGROUND

  • Estey EH. Acute myeloid leukemia: 2019 update on risk-stratification and management. Am J Hematol. 2018 Oct;93(10):1267-1291. doi: 10.1002/ajh.25214.

    PMID: 30328165BACKGROUND

  • Heitmann JS, Hagelstein I, Hinterleitner C, Roerden M, Jung G, Salih HR, Marklin M, Kauer J. Identification of CD318 (CDCP1) as novel prognostic marker in AML. Ann Hematol. 2020 Mar;99(3):477-486. doi: 10.1007/s00277-020-03907-9. Epub 2020 Jan 21.

    PMID: 31965270BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 14, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2022

Study Completion

March 1, 2023

Last Updated

January 22, 2021

Record last verified: 2021-01