NCT01999556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2016

Completed
Last Updated

April 21, 2022

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

November 26, 2013

Last Update Submit

April 19, 2022

Conditions

Leukemia, Myelogenous, Acute

Outcome Measures

Primary Outcomes (1)

  • Number of participants with the mutation for acute myelogenous leukemia.

    60 months

Study Arms (2)

Patient

Specimen Collection

Relative

Specimen Collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Lawrence Druhan, PH.D.

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

November 1, 2013

Primary Completion

December 22, 2016

Study Completion

December 22, 2016

Last Updated

April 21, 2022

Record last verified: 2021-11

Locations

US(1)