NCT00415207

Brief Summary

This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this retrospectively in patients who participated in clinical trials that are now closed. All patients had ovarian cancer and received paclitaxel/carboplatin chemotherapy after primary surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

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

December 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 8, 2011

Status Verified

December 1, 2006

Enrollment Period

1.7 years

First QC Date

December 21, 2006

Last Update Submit

August 4, 2011

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Keywords

CYP2C8MDR1PharmacogeneticsPaclitaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ovarian cancer

You may qualify if:

  • Patients enrolled in "TC/TEC" in Denmark, Sweden or Norway
  • Patients enrolled in "OVAR-9" in Denmark, Sweden or Norway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology, University of Southern Denmark

Odense, Denmark

Location

Related Publications (1)

  • Bergmann TK, Green H, Brasch-Andersen C, Mirza MR, Herrstedt J, Holund B, du Bois A, Damkier P, Vach W, Brosen K, Peterson C. Retrospective study of the impact of pharmacogenetic variants on paclitaxel toxicity and survival in patients with ovarian cancer. Eur J Clin Pharmacol. 2011 Jul;67(7):693-700. doi: 10.1007/s00228-011-1007-6. Epub 2011 Feb 16.

    PMID: 21327421RESULT

Biospecimen

Retention: SAMPLES WITH DNA

paraffin embedded biopsies

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Kim Brøsen, phd

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2008

Study Completion

December 1, 2010

Last Updated

August 8, 2011

Record last verified: 2006-12

Locations

DK(1)