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Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients

Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01049126
Enrollment
76
Registered
2010-01-14
Start date
2009-07-31
Completion date
2010-02-28
Last updated
2011-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

Late Stage

Brief summary

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

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.

Interventions

OTHERChemoFx

Chemoresponse Marker Assay

Sponsors

Precision Therapeutics
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026