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ChemoFx® PRO - A Post-Market Data Collection Study
This study is currently recruiting participants.
Verified by Precision Therapeutics, November 2009
First Received: April 25, 2008   Last Updated: November 2, 2009   History of Changes
Sponsor: Precision Therapeutics
Information provided by: Precision Therapeutics
ClinicalTrials.gov Identifier: NCT00669422
  Purpose

Chemoresponse assays (lab test) measure the effect that chemotherapy treatment has on a patient's cancer cells in the lab. This test has shown success in a retrospective study in predicting how an individual patient's tumor will respond to a given chemotherapy. In a retrospective study, it was demonstrated that patients treated with a regimen that the test said that a patient's cells would be sensitive to, corresponds to a 3 times longer progression free interval. This study will look for trends and common factors among different people's cancer and their sensitivities to chemotherapy treatments.


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

Study Type: Observational
Study Design: Case-Only, 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:
  • Physician reported outcome of 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 and biological growth factors [ Time Frame: 24-36 Months depending on Disease Status ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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.


Estimated Enrollment: 3000
Study Start Date: October 2006
Detailed Description:

The traditional treatment course for new cases of many gynecologic 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.

Resistance to chemotherapy cannot be predicted by either clinical or histological examination. Historically, the ex vivo sensitivity and resistance of tumor cells has been evaluated as a tool for predicting the clinical response of the patient to therapy. In this study, patients will be followed through treatment; the assay results will be compared to clinical outcomes that will be reported at regular intervals. 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 Observational 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:   Probability Sample
Study Population

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

Patients have a confirmed gynecologic 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 whose doctor 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 fot eh 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669422

  Show 68 Study Locations
Sponsors and Collaborators
Precision Therapeutics
  More Information

Additional Information:
Publications:
Responsible Party: Precision Therapeutics, Inc. ( Rebecca Tornari, Clinical Trials Project Manager )
Study ID Numbers: ChemoFx®PRO Study
Study First Received: April 25, 2008
Last Updated: November 2, 2009
ClinicalTrials.gov Identifier: NCT00669422     History of Changes
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2009