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OpenTrials
Completed

NCT Number: NCT01049126

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Precision Therapeutics, Inc.

Pittsburgh, Pennsylvania, 15203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ChemoFx

Other

Chemoresponse Marker Assay

Sponsors and collaborators

Lead sponsor

Precision Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jan 14, 2010
Registry last updated
Mar 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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