Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients
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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 |
| 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 |
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.
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| United States, Pennsylvania | |
| Precision Therapeutics, Inc. | |
| Pittsburgh, Pennsylvania, United States, 15203 | |
| 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 Adenoma 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 Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 23, 2013