A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

Status
Active
Cancer Type
Multiple Primaries
Trial Phase
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Health services research
NCD ID
NCT01271959
Protocol IDs
PT-207 (primary)
Study Sponsor
Precision Therapeutics, Incorporated

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.

Objectives

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.