NCT01049126

Brief Summary

The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 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

July 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

January 13, 2010

Last Update Submit

March 14, 2011

Conditions

Endometrial Cancer

Keywords

Late Stage

Study Arms (1)

Late stage endometrial cancer

Other: ChemoFx

Interventions

ChemoFxOTHER

Chemoresponse Marker Assay

Late stage endometrial cancer

Eligibility Criteria

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

Approximately 70 cases of late stage endometrial cancer that have had ChemoFx drug response marker results from August 2007 to January 31, 2009 will be included.

You may qualify if:

  • Case has an original pathology report showing stage III, IIIa, IIIb, IIIc, IV, IVa, IVb, or recurrent endometrial cancer.
  • Case includes a pathology or cytology report from initial diagnosis showing disease of one or more of the following histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.).
  • Case has been identified for pattern of response evaluation.
  • Case must have a commercial ChemoFx drug response marker final report.

You may not qualify if:

  • Cases of patients who were deceased prior to 1 cycle of chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Precision Therapeutics, Inc.

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Holly Gallion, MD

    Vice President, Clinical Affairs

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

February 1, 2010

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

US(1)