A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Precision Therapeutics
ClinicalTrials.gov Identifier:
NCT01271959
First received: January 5, 2011
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition
Solid Organ Tumors

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

Resource links provided by NLM:


Further study details as provided by Precision Therapeutics:

Primary Outcome Measures:
  • To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors. [ Time Frame: Analysis of assay-directed compliance will be conducted immediately after information is collected. ] [ Designated as safety issue: No ]
  • To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors. [ Time Frame: From date of first dose of on-study chemotherapy to date of death or last known alive. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA, RNA, and proteomic research will be conducted on excess tissue cells.


Enrollment: 167
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with solid tumor malignancies

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.
  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: NCT01271959

  Show 25 Study Locations
Sponsors and Collaborators
Precision Therapeutics
Investigators
Principal Investigator: Karl Williams, M.D. Precision Therapeutics, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Precision Therapeutics
ClinicalTrials.gov Identifier: NCT01271959     History of Changes
Other Study ID Numbers: PT-207
Study First Received: January 5, 2011
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Precision Therapeutics:
Ovarian
Fallopian Tube
Peritoneal
Uterine Neoplasms
Vulva
Endometrial
Cervical
Lung
Carcinoid
Sarcoma
Mesothelioma
Adenocarcinoma
Colorectal
Breast
Assay
Chemotherapy
Recurrent
Refractory
Persistent
Chemoresponse

ClinicalTrials.gov processed this record on September 30, 2014