Adult Acute Lymphoblastic LeukemiaNCT00188084
Description and Prognostic Evaluation of Four Biological Parameters of Blast Cells in Adult Acute Lymphoblastic Leukemia
An observational study of Adult Acute Lymphoblastic Leukemia, run by University Hospital, Angers at 1 site in France.
Trial summary
Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification, including cytogenetics. We want to study at diagnosis several blast cells parameters on frozen samples of GRAALL protocols enrolled patients: 1. Read more about this study
- Who is it for?
- Ages 15 to 59 years
- Conditions the study is for
- Adult Acute Lymphoblastic Leukemia
- What is being tested?
- DNA Index, S-Phase% and CD45 expression
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2003to Sep 2005
- 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 15 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All GRAALL 2003 and 2005 enrolled patients with available frozen blast cells
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CRLCC Centre Paul Papin
Angers, 49933
Agnès F CHASSEVENT, PhD, 33-(0)2-41-35-27-00, a.chassevent@unimedia.fr
Mathilde HUNAULT-BERGER, MD,PhD
About this study
Official title: Analysis of Four Biological Parameters at Diagnosis of Adult Acute Lymphoblastic Leukaemia: DNA Index, Percentage of Cells in S-Phase, CD45 Fluorescence Index, and Protein P16: Prognostic Study in Patients Enrolled in a Multicentric Trial
Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification, including cytogenetics. We want to study at diagnosis several blast cells parameters on frozen samples of GRAALL protocols enrolled patients:
- A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.
- The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by Western Blot analysis.
Read more
The comparison between these parameters, and main haematological data, will be followed by a prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete remission, and survival.
Combination of the studied parameters will allow to appreciate a clonal diversity. This will help to predict, at diagnosis, high probability of resistance to treatment.
- Conditions
- Adult Acute Lymphoblastic Leukemia
- Being tested
- DNA Index, S-Phase%, CD45 expression, P16 metabolic way
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA IndexProcedure or surgery
S-Phase%Procedure or surgery
CD45 expressionProcedure or surgery
P16 metabolic wayProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- French Innovative Leukemia Organisation
- Investigators
- Laurence M Baranger, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188084
- Sponsor's protocol ID
- PHRC03-02
- Other IDs
- GOELAMS 271-003
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 28 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Four Biological Parameters at Diagnosis of Adult Acute Lymphoblastic Leukaemia: DNA Index, Percentage of Cells in S-Phase, CD45 Fluorescence Index, and Protein P16: Prognostic Study in Patients Enrolled in a Multicentric Trial
- ClinicalTrials.gov ID
- NCT00188084
- Acronym / sponsor ID
- PHRC03-02
- Conditions
- Adult Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- French Innovative Leukemia Organisation
- Study start
- Nov 2003
- Study completion
- Sep 2005
- First posted
- 16 Sep 2005 (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.
Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification, including cytogenetics. We want to study at diagnosis several blast cells parameters on frozen samples of GRAALL protocols enrolled patients:
- A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.
- The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by Western Blot analysis.
The comparison between these parameters, and main haematological data, will be followed by a prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete remission, and survival.
Combination of the studied parameters will allow to appreciate a clonal diversity. This will help to predict, at diagnosis, high probability of resistance to treatment.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All GRAALL 2003 and 2005 enrolled patients with available frozen blast cells
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA Index | Procedure or surgery | – |
| S-Phase% | Procedure or surgery | – |
| CD45 expression | Procedure or surgery | – |
| P16 metabolic way | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2005.
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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.
Laurence M Baranger, MD principal investigator
University Hospital, Angers
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 Adult Acute Lymphoblastic Leukemia, run by University Hospital, Angers at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Oct 2005. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnès F CHASSEVENT, PhD (33-(0)2-41-35-27-00, a.chassevent@unimedia.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 28 Oct 2005.