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Analysis of Percutaneous Ablations for Cancer Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563679
First Posted: March 27, 2012
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyun Kevin Kim, Emory University
  Purpose

This is a study involving patients with cancer who are referred by their treating physician for percutaneous locoregional therapies.

Patient's clinical and radiology findings, pathology findings, survival, treatment responses, and complications after their locoregional therapy will be studied.


Condition
Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Analysis of Percutaneous Ablations for Cancer Treatment

Further study details as provided by Hyun Kevin Kim, Emory University:

Primary Outcome Measures:
  • Effect of percutaneous and transarterial treatments for cancer in quality of life [ Time Frame: 1 year ]
    Patients will complete the QOL questionnare during their follow up visits after procedure. 1 month, 3 months, 6 months and 1 year.


Secondary Outcome Measures:
  • response rate to percutaneous and transarterial treatment for cancer [ Time Frame: 1 month, 3 months, 6 months, 1 year. ]
    Patients will be followed up 1, 3, 6 and 1year intervals after procedure.


Enrollment: 26
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The efficacy of the percutaneous and transarterial treatments for solid tumors will be studied. Prospective study on patients who receive percutaneous locoregional therapies, including radiofrequency ablation (RFA), cryoablation, microwave ablation, IRE and chemical ablation for treatment of cancer will be performed.

Preoperative clinic chart, procedure note, postoperative chart, pre- and post-operative CT, MRI or Ultrasound, angiographic findings, biopsy results and pathologic findings, will be reviewed. Patient survival, treatment responses, complications after the therapy will be collected from clinic visits and clinical encounters.

Patient overall performance status before and after procedures will be assessed using the Quality of Life questionnaire (SF-36™ Health Survey).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo ablative therapy procedures, in the Interventional Radiology department as part of a clinical treatment for cancer.
Criteria

Inclusion Criteria:

  • 18yrs of age
  • Cancer diagnosis
  • Candidate for Locoregional therapy
  • Willingness to sign informed consent

Exclusion Criteria:

  • Unable to sign informed consent
  • Patients not eligible for locoregional therapies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563679


Locations
United States, Georgia
Emory University Hospital
Altanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Hyun S Kim, MD Emory University
  More Information

Responsible Party: Hyun Kevin Kim, Director of Interventional Radiology and Image-guided Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01563679     History of Changes
Other Study ID Numbers: IRB00054905
RAD2160-11 ( Other Identifier: Other )
First Submitted: March 12, 2012
First Posted: March 27, 2012
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Hyun Kevin Kim, Emory University:
cancer
locoregional therapies
RFA
Cryoablation
Microwave ablation
chemical ablation
Irreversible electroporation