ChemoFx® PRO - A Post-Market Data Collection Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Precision Therapeutics
ClinicalTrials.gov Identifier:
NCT00669422
First received: April 25, 2008
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.


Condition
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Uterine Neoplasms
Endometrial Cancer
Vaginal Cancer
Vulvar Cancer
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

Resource links provided by NLM:


Further study details as provided by Precision Therapeutics:

Primary Outcome Measures:
  • To collect physician reported outcomes after the first chemotherapy utilized following the receipt of a final report from ChemoFx® in solid tumor malignancies for the generation of hypotheses for further sub-study. [ Time Frame: 24-36 Months depending on Disease Status ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers. [ Time Frame: 24-36 Months depending on Disease Status ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Leftover tumor cells from the test and pathology slides will be collected and stored to look for potential genetic variations related to drug pathway genes to identify patterns associated with clinical outcome.


Enrollment: 2756
Study Start Date: October 2006
Study Completion Date: October 2012
Detailed Description:

The traditional treatment course for new cases of many cancers is cytoreductive surgery followed by chemotherapy. Unfortunately, despite high initial response rates to treatment, the majority of patients recur. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.

ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents—providing both sensitivity and resistance information. In a retrospective study, it was demonstrated that patients treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive to, corresponded to a 3 times longer progression free interval.

In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the patient progresses or a significant change in chemotherapy occurs. This data will be collected and analyzed to identify potential patient cohorts for the development of hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.

The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic and community-based physicians in the U.S. The patients will be treated with drugs and/or drug combinations based on the medical judgment of the treating physician. This study is not randomized.

  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 3,000 patients from 150 academic and community based physicians in the United States.

Patients have a confirmed solid tumor malignancy and their tissue specimen has been submitted to Precision Therapeutics, Inc. as part of the patient's medical care

Criteria

Inclusion Criteria:

  • Patient has been diagnosed with a solid tumor malignancy and their physician has received a final report for ChemoFx® after August 1, 2006
  • Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
  • Patient must be at least 18 years of age
  • Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.

Exclusion Criteria:

  • Patient pathology shows benign pathology for sample submitted
  • Patient is not indicated to receive chemotherapy for their disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669422

  Show 67 Study Locations
Sponsors and Collaborators
Precision Therapeutics
  More Information

Additional Information:
Publications:
Responsible Party: Precision Therapeutics
ClinicalTrials.gov Identifier: NCT00669422     History of Changes
Other Study ID Numbers: PT-206 ChemoFx® PRO Study
Study First Received: April 25, 2008
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Precision Therapeutics:
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Uterine Neoplasms
Vulvar Cancer
Endometrial Cancer
Cervical Cancer
Assay
Chemotherapy
Recurrent
Refractory
Persistent
Chemoresponse
Sensitivity
Precision Therapeutics
ChemoFx

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Vulvar Diseases
Vaginal Diseases

ClinicalTrials.gov processed this record on September 18, 2014