Dynamic Changes in the Levels of sCD62L and SPARC in Chronic Myeloid Leukemia Patients During Imatinib Treatment

NCT05387330 | Completed

• 1 other identifier: 9093595
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to monitor the levels of soluble L-selectin (sCD62L) and secreted protein acidic rich in cysteine (SPARC) in chronic phase chronic myeloid leukemia (CP-CML) patients at baseline and after three and six months of imatinib therapy and evaluated the effect of imatinib on their levels and correlated their levels to clinical and laboratory parameters.

Conditions

Chronic Myeloid Leukemia

Keywords

Soluble L-selectin, sCD62L, SPARC, Imatinib, CML

Outcome Measures

Primary Outcomes (1)

• Dynamic changes of sCD62L and SPARC levels in CP-CML patients during imatinib treatment

  Monitoring the changes in sCD62L and SPARC levels at baseline and after three and six months of imatinib treatment

  Baseline and after three and six months of treatment

Secondary Outcomes (1)

• Correlations of sCD62L or SPARC levels with laboratory and clinical parameters

  Baseline and after three and six months of treatment

Study Arms (2)

CP-CML patients

Twenty five newly diagnosed CP-CML patients. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits

Diagnostic Test: ELISA kit

Control

Ten matched controls were enrolled. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits

Diagnostic Test: ELISA kit

Interventions

ELISA kit DIAGNOSTIC_TEST

Sandwich ELISA kit for the accurate quantitative detection of sCD62L and SPARC in human plasma and serum samples.

CP-CML patients; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed CP-CML patients were invited to be enrolled in this study. Patients were diagnosed according to ELN guidelines. Full patient history taken and proper information sheets completed for all participants.

You may qualify if:

• Both sexes.
• Newly diagnosed patient with chronic phase, Philadelphia chromosome positive (Ph+) CML.
• Age ≥ 18 years.

You may not qualify if:

• Patients in blastic or accelerated phase of chronic myeloid leukemia.
• Previous treatment with Imatinib.
• Pregnancy and lactation.
• Severe hepatic dysfunction.
• Kidney dysfunction.
• Intolerant or incompliant to imatinib.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, 31511, Egypt

Location

Related Publications (4)

• Sonoyama J, Matsumura I, Ezoe S, Satoh Y, Zhang X, Kataoka Y, Takai E, Mizuki M, Machii T, Wakao H, Kanakura Y. Functional cooperation among Ras, STAT5, and phosphatidylinositol 3-kinase is required for full oncogenic activities of BCR/ABL in K562 cells. J Biol Chem. 2002 Mar 8;277(10):8076-82. doi: 10.1074/jbc.M111501200. Epub 2002 Jan 4.

  PMID: 11779872 BACKGROUND

• Krause DS, Lazarides K, Lewis JB, von Andrian UH, Van Etten RA. Selectins and their ligands are required for homing and engraftment of BCR-ABL1+ leukemic stem cells in the bone marrow niche. Blood. 2014 Feb 27;123(9):1361-71. doi: 10.1182/blood-2013-11-538694. Epub 2014 Jan 6.

  PMID: 24394666 BACKGROUND

• Sopper S, Mustjoki S, White D, Hughes T, Valent P, Burchert A, Gjertsen BT, Gastl G, Baldauf M, Trajanoski Z, Giles F, Hochhaus A, Ernst T, Schenk T, Janssen JJ, Ossenkoppele GJ, Porkka K, Wolf D. Reduced CD62L Expression on T Cells and Increased Soluble CD62L Levels Predict Molecular Response to Tyrosine Kinase Inhibitor Therapy in Early Chronic-Phase Chronic Myelogenous Leukemia. J Clin Oncol. 2017 Jan 10;35(2):175-184. doi: 10.1200/JCO.2016.67.0893. Epub 2016 Nov 7.

  PMID: 28056193 BACKGROUND

• Podhajcer OL, Benedetti L, Girotti MR, Prada F, Salvatierra E, Llera AS. The role of the matricellular protein SPARC in the dynamic interaction between the tumor and the host. Cancer Metastasis Rev. 2008 Sep;27(3):523-37. doi: 10.1007/s10555-008-9135-x.

  PMID: 18459035 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and serum blood samples

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmoud M Elkholy, Bachelor

  Clinical Pharmacy Department, Faculty of Pharmacy, Al Salam University in Egypt

  PRINCIPAL INVESTIGATOR

• Sahar M El-Haggar, Ph D

  Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University

  PRINCIPAL INVESTIGATOR

• Maryan W Fahmi, Ph D

  Medical oncology unit, Internal medicine Department, Faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Clinical Pharmacy

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: April 1, 2018
• Primary Completion: July 25, 2021
• Study Completion: December 28, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

EG (1)