CancerNCT01563679
Analysis of Percutaneous Ablations for Cancer Treatment
An observational study of Cancer, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo ablative therapy procedures, in the Interventional Radiology department as part of a clinical treatment for cancer.
Who may be able to join
- 18yrs of age
- Cancer diagnosis
- Candidate for Locoregional therapy
- Willingness to sign informed consent
Who cannot join
- Unable to sign informed consent
- Patients not eligible for locoregional therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Analysis of Percutaneous Ablations for Cancer Treatment
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.
Read the 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).
- Conditions
- Cancer
- Keywords
- cancer, locoregional therapies, RFA, Cryoablation, Microwave ablation, chemical ablation, Irreversible electroporation
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of percutaneous and transarterial treatments for cancer in quality of life
Patients will complete the QOL questionnare during their follow up visits after procedure. 1 month, 3 months, 6 months and 1 year.
Measured: 1 year
Secondary outcomes (1)
response rate to percutaneous and transarterial treatment for cancer
Patients will be followed up 1, 3, 6 and 1year intervals after procedure.
Measured: 1 month, 3 months, 6 months, 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Kevin Kim, Emory University
- Investigators
- Hyun S Kim, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563679
- Sponsor's protocol ID
- IRB00054905
- Other IDs
- RAD2160-11
- Status last verified
- May 2014
- First submitted
- 12 Mar 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Percutaneous Ablations for Cancer Treatment
- ClinicalTrials.gov ID
- NCT01563679
- Acronym / sponsor ID
- IRB00054905
- Conditions
- Cancer
- Keywords
- cancer, locoregional therapies, RFA, Cryoablation, Microwave ablation, chemical ablation, Irreversible electroporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo ablative therapy procedures, in the Interventional Radiology department as part of a clinical treatment for cancer.
Key inclusion criteria (4 listed)
- 18yrs of age
- Cancer diagnosis
- Candidate for Locoregional therapy
- Willingness to sign informed consent
Key exclusion criteria (2 listed)
- Unable to sign informed consent
- Patients not eligible for locoregional therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
response rate to percutaneous and transarterial treatment for cancer
Time frame: 1 month, 3 months, 6 months, 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun S Kim, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of percutaneous and transarterial treatments for cancer in quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.