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

April 19, 2022 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients must have a diagnosis of acute myelogenous leukemia. Family members of patients with acute myelogenous leukemia may be enrolled.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient
Specimen Collection
Relative
Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with the mutation for acute myelogenous leukemia.
Time Frame: 60 months
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

December 22, 2016

Study Completion (ACTUAL)

December 22, 2016

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (ESTIMATE)

December 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCI-HEM-SPEC-001
  • 00008179

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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