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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01999556
Other study ID # LCI-HEM-SPEC-001
Secondary ID 00008179
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date December 22, 2016

Study information

Verified date November 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date December 22, 2016
Est. primary completion date December 22, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
United States Levine Cancer Institute Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with the mutation for acute myelogenous leukemia. 60 months
See also
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Terminated NCT01085656 - A Phase I Clinical Trial of OXi4503 for Relapsed and Refractory AML and MDS Phase 1
Terminated NCT01158885 - Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia Phase 2