LeukemiaNCT02193100
Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center
An observational study of Leukemia, run by University of Louisville at 1 site in United States.
Trial summary
To characterize the metabolism of glucose by the leukemic cells in patients with leukemia before and after initial chemotherapy. To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells in leukemic patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2019
- 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: Leukemia Subjects-clinically diagnosed or histologically diagnosed leukemia Healthy Subjects-no record of diagnosed cancer or hematologic disorders
Who may be able to join
- Each of the criteria in the following section must be met in order for a patient to be eligible for enrollment.
- Only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study.
- All patients must have measurable quantities of leukemic blasts on peripheral blood detected with a CBC.
- No history of diabetes for the experimental group or the control group.
- Patients with known hepatitis C or HIV (AIDS) are excluded.
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
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- Subjects must have no known prior history of cancer or malignant blood disorders. -Where possible, follow up will be carried out to verify that no cancer has developed since the blood collection. This will be done by a phone call performed one month from sample to ask if new medical conditions have arisen.
- Subjects must have WBC, RBC, and platelet counts within normal range on CBC.
- Subjects with known hepatitis C or HIV (AIDS) are excluded.
- No history of Diabetes
- At least 30 years of age
- Preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- None listed in protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center-University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: PRE AND POST TREATMENT METABOLOMIC ANALYSIS OF LEUKEMIA: A Translational Clinical Trial of the Brown Cancer Center
To characterize the metabolism of glucose by the leukemic cells in patients with leukemia before and after initial chemotherapy.
To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells in leukemic patients.
Read the detailed description
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after C13-glucose administration at strategic time points of treatment.
To detect and measure 13C-labeled metabolic markers which may be present in the serum and urine of leukemic patients.
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after C13-glucose administration at strategic time points of treatment.
To detect and measure 13C-labeled metabolic markers which may be present in the serum and urine of leukemic patients.
- Conditions
- Leukemia
- Medical subject headings
- Leukemia
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 |
|---|---|---|
| 13C-glucose | experimental (13C-glucose) | |
| No glucose | control (no glucose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
Blood and urine samples will be taken before and after chemotherapy treatment for up to 6 months post treatment and analyzed for metabolic substances using nuclear magnetic resonance (NMR) spectroscopy with intergraded hyphenated mass spectrometry.
Measured: Baseline up to 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193100
- Sponsor's protocol ID
- BCC-BMT-13 Leuk Metabolomics
- Status last verified
- Jan 2016
- First submitted
- 12 Jun 2014
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE AND POST TREATMENT METABOLOMIC ANALYSIS OF LEUKEMIA: A Translational Clinical Trial of the Brown Cancer Center
- ClinicalTrials.gov ID
- NCT02193100
- Acronym / sponsor ID
- BCC-BMT-13 Leuk Metabolomics
- Conditions
- Leukemia
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Aug 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 17 Jul 2014 (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.
To characterize the metabolism of glucose by the leukemic cells in patients with leukemia before and after initial chemotherapy.
To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells in leukemic patients.
Detailed description
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after C13-glucose administration at strategic time points of treatment.
To detect and measure 13C-labeled metabolic markers which may be present in the serum and urine of leukemic patients.
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after C13-glucose administration at strategic time points of treatment.
To detect and measure 13C-labeled metabolic markers which may be present in the serum and urine of leukemic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13C-glucose | – | –experimental (13C-glucose) |
| No glucose | – | –control (no glucose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Leukemia Subjects-clinically diagnosed or histologically diagnosed leukemia Healthy Subjects-no record of diagnosed cancer or hematologic disorders
Key inclusion criteria (13 listed)
- Each of the criteria in the following section must be met in order for a patient to be eligible for enrollment.
- Only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study.
- All patients must have measurable quantities of leukemic blasts on peripheral blood detected with a CBC.
- No history of diabetes for the experimental group or the control group.
- Patients with known hepatitis C or HIV (AIDS) are excluded.
Key exclusion criteria (1 listed)
- None listed in protocol
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
Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
Time frame: Baseline up to 6 months post treatment
Blood and urine samples will be taken before and after chemotherapy treatment for up to 6 months post treatment and analyzed for metabolic substances using nuclear magnetic resonance (NMR) spectroscopy with intergraded hyphenated mass spectrometry.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University of Louisville 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 13 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: withdrawn, as of the sponsor's last update on 29 Dec 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR) (time frame: Baseline up to 6 months post treatment). 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 29 Dec 2017.