Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients - Full Text View

Sponsor:	Precision Therapeutics
Information provided by:	Precision Therapeutics
ClinicalTrials.gov Identifier:	NCT01049126

Purpose

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

Condition	Intervention
Endometrial Cancer	Other: ChemoFx

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Retrospective
Official Title:	Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Precision Therapeutics:

Enrollment:	76
Study Start Date:	July 2009
Study Completion Date:	February 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Late stage endometrial cancer	Other: ChemoFx Chemoresponse Marker Assay Other Name: ChemoFx

Detailed Description:

This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 70 cases will be collected from approximately 10 study sites and correlated to the ChemoFx drug response marker results. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy. Overall Survival will be measured from the start of chemotherapy to the actual date of death.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049126

Locations

United States, Pennsylvania
Precision Therapeutics, Inc.
Pittsburgh, Pennsylvania, United States, 15203

Sponsors and Collaborators

Precision Therapeutics

Investigators

Study Chair:

Holly Gallion, MD

Vice President, Clinical Affairs

More Information

No publications provided

Responsible Party:	Holly Gallion, MD, Precision Therapeutics
ClinicalTrials.gov Identifier:	NCT01049126 History of Changes
Other Study ID Numbers:	PT-106
Study First Received:	January 13, 2010
Last Updated:	March 14, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Precision Therapeutics:

Late Stage

Additional relevant MeSH terms:

Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms

Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on February 09, 2012