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LCI-HEM-SPEC-001: Tissue Collection for Genetic Analysis of Acute Myelogenous Leukemia

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01999556
Collaborator
(none)
6
Enrollment
1
Location
37.7
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain high quality specimens for molecular studies for the identification and characterization of genetic mutations involved in the pathogenesis of familial myeloid malignancies. Specimens obtained will be de-identified, linked to basic clinical data, and sent to Washington University (Division of Oncology, St. Louis, MO) for molecular analyses. Some specimens sent to Washington University may also be used for quality control analyses.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a specimen collection study for patients receiving standard of care treatment for AML. Specimens collected will be 1) bone marrow biopsy and aspiration, 2) peripheral blood, 3) skin punch biopsy, and 4) oral rinse. Collection of these specimens will be at timepoints determined by the patient's standard of care and their physician Investigator.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    LCI-HEM-SPEC-001: Tissue Collection for Familial Acute Myelogenous Leukemia Genetic Analysis
    Study Start Date :
    Nov 1, 2013
    Actual Primary Completion Date :
    Dec 22, 2016
    Actual Study Completion Date :
    Dec 22, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Patient

    Specimen Collection
    Relative

    Specimen Collection

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with the mutation for acute myelogenous leukemia. [60 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria

    • Patients must have a diagnosis of acute myelogenous leukemia.

    • Family members of patients with acute myelogenous leukemia may be enrolled.

    • Informed consent must be provided by the patient or his/her legal guardian in accord with the practices of Levine Cancer Institute and Atrium Health.

    Exclusion Criteria

    • Known infection with Hepatitis B or C, HTLV, or HIV.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Levine Cancer Institute Charlotte North Carolina United States 28204

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    • Principal Investigator: Lawrence Druhan, PH.D., Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01999556
    Other Study ID Numbers:
    • LCI-HEM-SPEC-001
    • 00008179
    First Posted:
    Dec 3, 2013
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Apr 21, 2022