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Trial record 9 of 16 for:    CFC1

Comparison Between Fluorescent in Situ Hybridization Panels and Karyotyping in Hematological Neoplasms

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ClinicalTrials.gov Identifier: NCT03719183
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
South Egypt Cancer Institute
Information provided by (Responsible Party):
Ahmed Makboul Ahmed Makboul, Assiut University

Brief Summary:

Conventional cytogenetic studies have been the gold standard for more than five decades for detecting genetic alterations that are greater than 10 Mb (mega base pairs) in size (Peterson et al. 2015). Conventional cytogenetic studies have paved the way in identifying specific chromosomal aberrations associated with clinically and morphologically definitive subsets of hematological neoplasms (Sreekantaiah 2007).

Fluorescence in situ hybridization (FISH) has become a reliable and rapid complementary test in targeting critical genetic events associated with diagnostics and prognosis in hematological neoplasms (Sreekantaiah 2007).

With the lack of an evidence-based standardized algorithmic approach, misuse and overutilization of laboratory tests are common and result in increased health care costs and patient care complexity. In the current health care environment, which increasingly focuses on value and efficiency, it is critical for pathologists and clinicians to effectively navigate this environment and judiciously incorporate these high-complexity and expensive techniques into routine patient care. Going forward, cost-effective integration and appropriate test utilization will be a top priority across all medical disciplines. While conventional karyotyping provides a comprehensive view of the genome, FISH can detect cryptic or submicro¬scopic genetic abnormalities and identify recurrent genetic abnormalities in nondividing cells. As a consequence, it is commonly extrapolated that FISH will improve the sensitivity of detecting all genetic abnormalities compared with conventional karyotyping analysis. This assumption has then been translated in clinical practice to having clinicians and pathologists routinely ordering both conventional karyotyp¬ing and FISH studies in patients with hematological neoplasms. Depending on how comprehensive the FISH panel is, the cost for this test¬ing may be quite expensive, and its additive value remains questionable (He et al. 2015).

It is common practice for laboratories to use FISH panels in conjunction with karyotyping both in diagnostic specimens and during follow-up to monitor response to therapy (Wheeler et al. 2018).


Condition or disease Intervention/treatment
Hematologic Neoplasms Diagnostic Test: Conventional Cytogenetics Studies Diagnostic Test: Fluorescent in Situ Hybridization (FISH) Panels

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Diagnostic Yield of Fluorescent in Situ Hybridization Panels Against Conventional Cytogenetic Studies in Hematological Neoplasms
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Acute Myeloid Leukemia (AML) group

Patients who are diagnosed as Acute Myeloid Leukemia based on peripheral blood, bone marrow aspiration and immunophenotyping.

Fluorescent in Situ Hybridization (FISH) Panels for AML and Conventional Cytogenetics Studies will be performed for AML patients.

Diagnostic Test: Conventional Cytogenetics Studies
Metaphase cytogenetic studies will be performed in all cases according to standard methods. Chromosome preparations will be G-banded using trypsin and Giemsa, and karyotypes will be described according to the International System for Human Cytogenetic Nomenclature (ISCN) 2016.
Other Name: Karyotyping

Diagnostic Test: Fluorescent in Situ Hybridization (FISH) Panels

AML Panel includes:

  • t(8;21) (RUNX1-RUNX1T1).
  • inv(16), t(16;16) (CBFB-MYH11).
  • t(9;22) (BCR-ABL).
  • 11q23 KMT2A rearrangements.
  • inv(3) MECOM rearrangements.
  • NUP214 rearrangements.

Acute Promyelocytic Leukemia panel includes:

  • t(15;17) (PML-RARA).
  • 17q RARA rearrangements

CML Panel includes:

  • t(9;22) (BCR-ABL).
  • Isochromosome (17) by FISH.

Chronic Myeloid Leukemia (CML) group

Patients who are diagnosed as Chronic Myeloid Leukemia based on clinical data, peripheral blood, bone marrow examination and cytogenetic and molecular studies (BCR-ABL).

Fluorescent in Situ Hybridization (FISH) Panels for CML and Conventional Cytogenetics Studies will be performed for CML patients.

Diagnostic Test: Conventional Cytogenetics Studies
Metaphase cytogenetic studies will be performed in all cases according to standard methods. Chromosome preparations will be G-banded using trypsin and Giemsa, and karyotypes will be described according to the International System for Human Cytogenetic Nomenclature (ISCN) 2016.
Other Name: Karyotyping

Diagnostic Test: Fluorescent in Situ Hybridization (FISH) Panels

AML Panel includes:

  • t(8;21) (RUNX1-RUNX1T1).
  • inv(16), t(16;16) (CBFB-MYH11).
  • t(9;22) (BCR-ABL).
  • 11q23 KMT2A rearrangements.
  • inv(3) MECOM rearrangements.
  • NUP214 rearrangements.

Acute Promyelocytic Leukemia panel includes:

  • t(15;17) (PML-RARA).
  • 17q RARA rearrangements

CML Panel includes:

  • t(9;22) (BCR-ABL).
  • Isochromosome (17) by FISH.




Primary Outcome Measures :
  1. Comparing Diagnostic Yield of Fluorescent in Situ Hybridization Panels Against Conventional Cytogenetic Studies [ Time Frame: 2 years ]
    comparing the diagnostic yield between FISH panels and conventional cytogenetic studies in hematological neoplasms.


Biospecimen Retention:   Samples With DNA
Peripheral blood or Bone marrow aspiration samples


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed AML or CML.
Criteria

Inclusion Criteria:

  • Adult and pediatric patients with newly diagnosed hematological neoplasms:

    • Acute Myeloid Leukemia (AML).
    • Chronic Myeloid Leukemia (CML).

Exclusion Criteria:

  • N.A.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719183


Contacts
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Contact: Ahmed Makboul, M.Sc. +201006291813 a.makboul1987@gmail.com

Sponsors and Collaborators
Assiut University
South Egypt Cancer Institute
Investigators
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Study Director: Eman Mosaad, PhD South Egypt Cancer Institute

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Responsible Party: Ahmed Makboul Ahmed Makboul, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03719183     History of Changes
Other Study ID Numbers: AssiutU-SECI-Cytogenetic 100
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases