NCT00640692

Brief Summary

The purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2007

Typical duration for all trials

Status
withdrawn

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, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

March 18, 2008

Last Update Submit

October 31, 2019

Conditions

Gastrointestinal Neoplasm

Keywords

Gastrointestinal stromal tumorGISTSunitinibImatinib

Study Arms (2)

1

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled in Pfizer A6181112

You may qualify if:

  • Patients enrolled in Pfizer A6181112

You may not qualify if:

  • Patients who do not consent for analysis of their tumor in this companion study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA from tumor samples

MeSH Terms

Conditions

Gastrointestinal NeoplasmsGastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Christopher L Corless, MD, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

December 1, 2007

Primary Completion

September 1, 2009

Study Completion

April 1, 2011

Last Updated

November 4, 2019

Record last verified: 2019-10