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| 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 |
|---|
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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 |
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 |
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 |
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
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 68 Study Locations
More Information
| 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 |
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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 |
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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 |