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| Sponsor: | Precision Therapeutics |
|---|---|
| Information provided by: | Precision Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01048814 |
Purpose
The purpose of this study is to improve upon and validate the prognostic and/or predictive accuracy of a drug response marker by the development of improved alternative algorithms based on the actual clinical outcome of retrospective cases.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
Other: ChemoFx |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Retrospective Study to Develop a Training Set for a Cross Validated Chemoresponse Marker Algorithm in Cases With Ovarian, Peritoneal or Fallopian Tube Cancer |
| Estimated Enrollment: | 512 |
| Study Start Date: | August 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Ovarian, Peritoneal, Fallopian Cancer
Recurrent, Peristent or Refractory
|
Other: ChemoFx
Chemoresponse Marker Assay
Other Name: ChemoFx
|
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 512 cases will be collected from approximately 30 sites and correlated to the secondary endpoints identified in order to produce a training set that will incorporate additional improvements to the existing ChemoFx scoring system. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Approximately 512 cases of ovarian, peritoneal or fallopian tube, recurrent, persistent, or refractory cancer that have had ChemoFx drug response marker results for NCCN recommended second line therapy from August 2006 to January 31, 2009 will be included in the compilation of the training set. Cases will be selected sequentially from each participating clinical site.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Precision Therapeutics, Inc. | |
| Pittsburgh, Pennsylvania, United States, 15203 | |
| Study Director: | Holly Gallion, MD | Vice President, Clinical Affairs |
More Information
| Responsible Party: | Holly Gallion, MD, Precision Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01048814 History of Changes |
| Other Study ID Numbers: | PT-103 |
| Study First Received: | January 13, 2010 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |