Clinical trial NCT01271959: A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
Official title: A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Solid Organ Tumors
Keywords: Ovarian
Fallopian Tube
Peritoneal
Uterine Neoplasms
Vulva
Endometrial
Cervical
Lung
Carcinoid
Sarcoma
Mesothelioma
Adenocarcinoma
Colorectal
Breast
Assay
Chemotherapy
Recurrent
Refractory
Persistent
Chemoresponse
Lead sponsor: Precision Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with solid tumor malignancies

Brief summary: The purpose of this research study is to collect information from patient's medical records that had a test called ChemoFx® ordered and to understand how doctors may have used the results of the ChemoFx® to treat patients with cancer.

Detailed description: While studies support the clinical use of ChemoFx® in cancer patients, additional data are needed to further assess the utilization of this product in clinical practice. Such post-market data and information could be employed for product improvement as well as for the development of standards and regulations. This is a multicenter registry study of 3,000 patients with solid tumors. The study is not randomized, nor is it interventional in that the treating physician is free to choose how to employ ChemoFx® results in the clinical management of individual patients. Sites will be selected by Precision's clinical trials team based on past commercial usage of ChemoFx®.

Subjects who may be enrolled in this study are those who have been diagnosed with a solid tumor malignancy and for whom ChemoFx® has been ordered. ChemoFx® is ordered through the normal commercial process and is therefore billed to the patient's medical insurance.

All subjects will be appropriately consented before any study-specific data are collected. A limited dataset of patient demographics, oncology history, and therapeutic intervention will be collected in addition to ChemoFx® assay usage. Subjects will be treated based on the medical judgment of their treating physician(s). Patient survival data will be collected up to five years following the ChemoFx® commercial order. Additional disease progression data may be collected by Precision's CRAs at participating sites.

Optional Cell Research

Informed consent will be obtained to document subject's consent to use excess cells remaining in Precisions' commercial laboratory for additional research. This portion of the study may involve DNA, RNA, and proteomic research. To ensure the anonymity of each subject, any identifiers that would link the sample to the subject will be removed. The samples would then have gene expression profiling and or quantitative protein expression analysis performed. The goal of the research would be to identify a set of informative genes, intermediaries, and proteins and develop predictive algorithm(s) that seek to link the expression level of the gene, gene signature, intermediary, or protein to the clinical outcome of the patient. This portion of the study does not require any additional subject procedures. Neither physicians nor their patients will receive the results of the research performed. Results will not be placed in the subjects health care records and will not affect their medical care.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diagnosis of solid tumor malignancy;
* Medically indicated to receive chemotherapy;
* Fresh tissue submitted from the solid tumor malignancy for testing with the ChemoFx® assay after August, 2006;
* Final ChemoFx® assay report is available;
* Subject must be at least 18 years of age;
* Subject must sign and date an IRB approved ICF.

Exclusion Criteria:

* Enrolled in PT-103, PT-106, PT-206, PT-301, or PT-304;
* Pregnant or lactating subjects;
* Subjects are not indicated to receive chemotherapy for their disease;
* Subjects with psychiatric or addictive disorders that would preclude obtaining informed consent.

Primary outcomes:
measure: To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
timeFrame: Analysis of assay-directed compliance will be conducted immediately after information is collected.
measure: To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.
timeFrame: From date of first dose of on-study chemotherapy to date of death or last known alive.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardio-Thoracic Surgeons, P.C.
state: Alabama
city: Oakland
country: United States
facility: Hematology Oncology Associates
state: California
city: Boynton Beach
country: United States
facility: Collaborative Research Group
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Oncology Associates, P.A.
state: Florida
city: Hollywood
country: United States
facility: The Center For Gynecologic Oncology
state: Florida
city: Miami
country: United States
facility: GYN Oncology of Miami
state: Florida
city: Miami
country: United States
facility: Miami International Surgical Services
state: Florida
city: Orlando
country: United States
facility: Orlando Cardiovascular Institute PA
state: Florida
city: Skokie
country: United States
facility: Edward H. Kaplan, M.D. & Associates
state: Illinois
city: Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital Clinical Research Center
state: Kentucky
city: Paducah
country: United States
facility: Oncology Associates of West Kentucky
state: Kentucky
city: Grand Blanc
country: United States
facility: Grand Blanc Surgical Specialist
state: Michigan
city: Albany
country: United States
facility: Albany Thoracic & Esophageal Surgery
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology
state: New York
city: Flushing
country: United States
facility: The New York Hospital Medical Center of Queens
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Cleveland
country: United States
facility: Center for Clinical Research and Technology University Hospitals of Cleveland
state: Ohio
city: Erie
country: United States
facility: The Regional Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: Barry S Siller MD
state: Texas
city: Houston
country: United States
facility: Colorectal Surgical Associates
state: Texas
city: Houston
country: United States
facility: Northwest Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Morgantown
country: United States
facility: Heiskell, King, Burns & Tallman Surgical Associates, Inc.
state: West Virginia
Study officials:
affiliation: Precision Therapeutics, Inc.
name: Karl Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References: