Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eastern Ablation Registry for Solid Tumor (EAST) (EAST)

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.
 
ClinicalTrials.gov Identifier: NCT03362749
Recruitment Status : Unknown
Verified April 2017 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Local tumor ablation is among the major anti-tumor modalities worldwide. Given the number of changes that have taken place in the field of tumor ablation in the past 10 years, it is our intention to ensure that this highly utilized standardization continues to remain relevant as it unites all investigators and clinicians practicing interventional oncology by providing a common language to describe therapies and outcomes, develop studies, and communicate with other medical specialties. In an attempt to attain greater Asian-wide adoption, the investigators will initiate the registry system for local tumor ablation in Taiwan, China, Korea, Singapore, Hong Kong and Thailand.

Condition or disease Intervention/treatment
Solid Tumor Including Thyroid, Bone, Liver, Pancreas Other: RFA, MWA, cryo and IRE

Detailed Description:

Local tumor ablation is among the major anti-tumor modalities worldwide. Although surgical resection is potentially curative and beneficial to long-term patient survival, the majority of patients are deemed unresectable.

In 2003, the International Working Group on Image-Guided Tumor Ablation published a document titled "Image-Guided Tumor Ablation: Proposal for Standardization of Terms and Reporting Criteria". Ten years later, the field of tumor ablation continues to evolve. Tumor ablation modalities that were still being developed at the time of original preparation, such as microwave, irreversible electroporation (IRE), have been introduced and clinical niches are being defined. Preliminary clinical studies have matured into larger longer-term series with 5- and 10-year follow-up data on par with the surgical and medical oncology literature. Over the interim, our initial document has also given rise to several additional position statements within the field of interventional oncology and been the source for more focused societal statements on tumor ablation of liver, kidney, pancreas and musculoskeletal tumors.

Given the number of changes that have taken place in the field of tumor ablation in the past 10 years, it is our intention to ensure that this highly utilized standardization continues to remain relevant as it unites all investigators and clinicians practicing interventional oncology by providing a common language to describe therapies and outcomes, develop studies, and communicate with other medical specialties. In an attempt to attain greater Asian-wide adoption, the investigators will initiate the registry system for local tumor ablation in Taiwan, China, Korea, Singapore, Hong Kong and Thailand.

The main objective of the registry will be "improved precision and communication in this field that leads to more accurate comparison of technologies and results and ultimately to improved patient outcomes". This study aims to establish a local tumor ablation registry in Taiwan and collect real-life data regarding the safety, efficacy, changes in clinical presentation, and practice pattern of treatment in patients with clinically confirmed solid tumor including thyroid, bone, liver, pancreas and those which are scheduated to be treated by local tumor ablation including radiofrequency ablation, microwave ablation, cryoablation and irreversible electroporation The results collected from this registry and the analyses generated will be valuable reference for physicians in choosing treatment strategy in the future.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eastern Ablation Registry for Solid Tumor (EAST)
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Intervention Details:
  • Other: RFA, MWA, cryo and IRE
    local tumor ablation


Primary Outcome Measures :
  1. To observe the efficacy of local tumor ablation [ Time Frame: through study completion, an average of 1 year ]
    Response rate (RR) to local tumor ablation


Secondary Outcome Measures :
  1. The effect of local tumor ablation [ Time Frame: up to 3 years ]
    time-to-progression

  2. To observe the survival rate [ Time Frame: up to 3 years ]
    overall survival (OS)

  3. To observe the progression-free survival rate [ Time Frame: up to 3 years ]
    to observe the progression-free survival



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving local tumor ablation for solid tumor including thyroid, bone, liver, pancreas and those which are scheduated to be treated by local ablation including radiofrequency ablation, microwave ablation, cryoablation and irreversible electroporation will be screened for eligibility.
Criteria

Inclusion Criteria:

  • Patients who meet all inclusion criteria will be included:

    1. Males or non-pregnant females, at least 18 years of age (inclusive)
    2. Patients with clinically confirmed solid tumor including thyroid, bone, liver, pancreas and those which are scheduated to be treated by local tumor ablation including radiofrequency ablation, microwave ablation, cryoablation and irreversible electroporation
    3. Patients who have provided written informed consent
    4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
    5. American Society of Anaesthesiologists (ASA) score ≤ 3

Exclusion Criteria:

Patients who meet any exclusion criteria will be excluded:

  1. The procedure of local ablation is not completed due to machine or patient problem
  2. Received treatment with an investigational agent/ procedure within 30 days prior to local ablation
  3. Known history of HIV infection
  4. Women who are pregnant
  5. Life expectancy is less than 3 months

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): NCT03362749


Contacts
Layout table for location contacts
Contact: Kai-Wen Huang, M.D. Ph.D 886-2-23123456 ext 66144 skywing@ntuh.gov.tw

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Kai-wen Huang, MD, PhD       skywing@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kai-Wen Huang, M.D. Ph.D National Taiwan University Hospital
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03362749    
Other Study ID Numbers: 201703032RIND
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: April 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms