Leukemia, Myelogenous, AcuteNCT01999556
LCI-HEM-SPEC-001: Tissue Collection for Genetic Analysis of Acute Myelogenous Leukemia
An observational study of Leukemia, Myelogenous, Acute, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Myelogenous, Acute
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 22 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients must have a diagnosis of acute myelogenous leukemia. Family members of patients with acute myelogenous leukemia may be enrolled.
Who may be able to join
- 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.
Who cannot join
- Known infection with Hepatitis B or C, HTLV, or HIV.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: 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.
Read the 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.
- Conditions
- Leukemia, Myelogenous, Acute
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Specimen Collection | |
| Relative | Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with the mutation for acute myelogenous leukemia.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelogenous, AcuteStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Druhan, PH.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999556
- Sponsor's protocol ID
- LCI-HEM-SPEC-001
- Other IDs
- 00008179
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2013
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCI-HEM-SPEC-001: Tissue Collection for Familial Acute Myelogenous Leukemia Genetic Analysis
- ClinicalTrials.gov ID
- NCT01999556
- Acronym / sponsor ID
- LCI-HEM-SPEC-001
- Conditions
- Leukemia, Myelogenous, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Specimen Collection |
| Relative | – | –Specimen Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must have a diagnosis of acute myelogenous leukemia. Family members of patients with acute myelogenous leukemia may be enrolled.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Known infection with Hepatitis B or C, HTLV, or HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with the mutation for acute myelogenous leukemia.
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Druhan, PH.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myelogenous, Acute, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with the mutation for acute myelogenous leukemia. (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.