NCT01448759

Brief Summary

The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

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

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

October 6, 2011

Last Update Submit

April 23, 2015

Conditions

Tumors

Keywords

Patients receiving docetaxel or paclitaxel. All tumors.

Outcome Measures

Primary Outcomes (1)

  • Evaluation of plasma alcohol

    Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel)

    One year

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient under 18.
  • Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
  • Patient deprived of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • LE TOURNEAU Christophe, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 7, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

FR(1)