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Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases
This study has been completed.

First Received on January 13, 2010.   Last Updated on June 2, 2011   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Precision Therapeutics:

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

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 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
Study Population

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.

Criteria

Inclusion Criteria:

  • Case has an original pathology report showing, epithelial ovarian, peritoneal, or fallopian tube carcinoma.
  • Cases must meet one of the following classifications: Recurrent: Complete Response following primary therapy and a period of absence of no measurable disease; Persistent: Partial Response following 6 cycles of a platinum based therapy with measurable disease remaining or Refractory: Stable Disease or Progressive Disease during primary platinum therapy.
  • Case must have a commercial ChemoFx drug response marker final report

Exclusion Criteria:

  • Cases with evidence of synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtype, including papillary serous, clear cell, or other FIGO Grade 3 lesion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048814

Locations
United States, Pennsylvania
Precision Therapeutics, Inc.
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
Precision Therapeutics
Investigators
Study Director: Holly Gallion, MD Vice President, Clinical Affairs
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 09, 2012