Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01380587
First received: June 22, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.


Condition
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Number of patients with poor prognosis and high levels of XCL1 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of patients with high levels of XCL1, expression of its receptor and other cytokines.

  • Number of patients with poor prognosis and high levels of cytokines [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measurements obtained will be evaluated to assess the prognosis of patients and made correlations with the concentration of IL-1β, IL-2 and XCL1 as well as the relationship XCR1 XCL1 and in leukemic cells.


Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells, blasts


Enrollment: 25
Study Start Date: November 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Lymphoblastic Leukemia
We will invite patients with newly diagnosed acute lymphoblastic leukemia in the Department of Hematology, who had not received anticancer therapy and regardless the subtype and immunophenotype of the disease.

Detailed Description:

Each year approximately 256,000 children and adults around the world develop a form of leukemia, and 209,000 died from it. Recently, some studies have evaluated the relationship between the concentration of some cytokines and prognosis of acute lymphoblastic leukemia. XCL1 is a lymphotactin that belongs to a cytokine subfamily called C or γ with only one cysteine in the N-terminal residue. It has been found with significant expression of receptor mRNA XCL1 (XCR1) in T and B lymphocytes and related to hematological neoplasms. For these reasons, XCL1 could be a efficient marker of prognosis in patients with acute lymphoblastic leukemia.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will invite patients with newly diagnosed acute lymphoblastic leukemia , who had not received anticancer therapy and regardless the subtype and immunophenotype of the disease.

Criteria

Inclusion Criteria:

Patients with newly diagnosed acute lymphoblastic leukemia .

Exclusion Criteria:

  • Patients with prior treatment with chemotherapeutic agents.
  • Patients treated with immunosuppressants.
  • Patients under 12 months old.
  • Patients with a diagnosis or history of autoimmune diseases.
  • Patients with a diagnosis or history of immunosuppressive diseases.
  • Patients who do not agree to sign a Letter of Informed Consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380587

Locations
Mexico
Hospital Universitario Dr. Jose E. Gonzalez UANL
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Cesar H Gutierrez Aguirre, MD Hospital Universitario Dr. Jose E. Gonzalez UANL
  More Information

Publications:
Responsible Party: David Gomez Almaguer, MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01380587     History of Changes
Other Study ID Numbers: XCL1 in ALL
Study First Received: June 22, 2011
Last Updated: August 26, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
ALL
XCL1
Cytokines
Prognosis

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014