Eastern Ablation Registry for Solid Tumor (EAST)

NCT ID: NCT03362749

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2023-12-30

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.

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.

Conditions

Solid Tumor Including Thyroid, Bone, Liver, Pancreas

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

RFA, MWA, cryo and IRE

local tumor ablation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai-Wen Huang, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kai-Wen Huang, M.D. Ph.D

Role: CONTACT

skywing@ntuh.gov.tw

886-2-23123456 ext. 66144

Facility Contacts

Kai-wen Huang, MD, PhD

Role: primary

skywing@ntuh.gov.tw

Other Identifiers

201703032RIND

Identifier Type: -

Identifier Source: org_study_id