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

NCT ID: NCT01999556

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia, Myelogenous, Acute

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient

Specimen Collection

No interventions assigned to this group

Relative

Specimen Collection

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence Druhan, PH.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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00008179

Identifier Type: -

Identifier Source: secondary_id

LCI-HEM-SPEC-001

Identifier Type: -

Identifier Source: org_study_id

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