TumorsALCOOTAXNCT01448759
Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel
A study testing blood sampling in people with Tumors, run by Institut Curie at 1 site in France.
Trial summary
The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- blood sampling
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Feb 2012
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule.
- Patient with bitherapy are eligible only if the taxane is the first infusion.
- All type of tumor.
- Age>18 years old.
- Signed written informed consent.
Who cannot join
- Patient under 18.
- Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
- Patient deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion
The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.
Read the detailed description
In this study, there is no experimental treatment, or experimental care.
- Conditions
- Tumors
- Being tested
- blood sampling
- Keywords
- Patients receiving docetaxel or paclitaxel. All tumors.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
Other: Blood sampling 10mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of plasma alcohol
Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LE TOURNEAU Christophe, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448759
- Sponsor's protocol ID
- IC 2011-03
- Acronym
- ALCOOTAX
- Status last verified
- Apr 2015
- First submitted
- 6 Oct 2011
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion
- ClinicalTrials.gov ID
- NCT01448759
- Acronym / sponsor ID
- ALCOOTAX / IC 2011-03
- Conditions
- Tumors
- Keywords
- Patients receiving docetaxel or paclitaxel. All tumors.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Oct 2011 (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 evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.
Detailed description
In this study, there is no experimental treatment, or experimental care.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule.
- Patient with bitherapy are eligible only if the taxane is the first infusion.
- All type of tumor.
- Age>18 years old.
- Signed written informed consent.
Key exclusion criteria (3 listed)
- Patient under 18.
- Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
- Patient deprived of liberty.
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 |
|---|---|---|
| blood samplingOther: Blood sampling 10mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient. | Other | – |
Primary outcome
Evaluation of plasma alcohol
Time frame: One year
Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel)
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 24 Apr 2015.
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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.
LE TOURNEAU Christophe, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Tumors, run by Institut Curie 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 5 inclusion and 3 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 24 Apr 2015. 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?
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?
Evaluation of plasma alcohol (time frame: One year). 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 24 Apr 2015.