Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases

NCT01048814 | Completed

• 1 other identifier: PT-103
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Study Arms (1)

Ovarian, Peritoneal, Fallopian Cancer

Recurrent, Peristent or Refractory

Other: ChemoFx

Interventions

ChemoFx OTHER

Chemoresponse Marker Assay

Ovarian, Peritoneal, Fallopian Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Precision Therapeutics: lead

Study Sites (1)

Precision Therapeutics, Inc.

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Holly Gallion, MD

  Vice President, Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: August 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 3, 2011

Record last verified: 2011-06

Locations

US (1)