Solid Tumor Including Thyroid, Bone, Liver, PancreasEASTNCT03362749
Eastern Ablation Registry for Solid Tumor (EAST)
An observational study of Solid Tumor Including Thyroid, Bone, Liver, Pancreas, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Including Thyroid, Bone, Liver, Pancreas
- What is being tested?
- RFA, MWA, cryo and IRE
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2017to 30 Dec 2023
- 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 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.
Who may be able to join
- Patients who meet all inclusion criteria will be included:
- Males or non-pregnant females, at least 18 years of age (inclusive)
- 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
- Patients who have provided written informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- American Society of Anaesthesiologists (ASA) score ≤ 3
Who cannot join
- Patients who meet any exclusion criteria will be excluded:
- The procedure of local ablation is not completed due to machine or patient problem
- Received treatment with an investigational agent/ procedure within 30 days prior to local ablation
- Known history of HIV infection
- Women who are pregnant
- Life expectancy is less than 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Kai-wen Huang, MD, PhD, skywing@ntuh.gov.tw
About this study
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.
Read the 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.
- Being tested
- RFA, MWA, cryo and IRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA, MWA, cryo and IREOther
local tumor ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the efficacy of local tumor ablation
Response rate (RR) to local tumor ablation
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
The effect of local tumor ablation
time-to-progression
Measured: up to 3 years
To observe the survival rate
overall survival (OS)
Measured: up to 3 years
To observe the progression-free survival rate
to observe the progression-free survival
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Sep 2017
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor Including Thyroid, Bone, Liver, PancreasStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, M.D. Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362749
- Sponsor's protocol ID
- 201703032RIND
- Acronym
- EAST
- Status last verified
- Oct 2022
- First submitted
- 22 May 2017
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eastern Ablation Registry for Solid Tumor (EAST)
- ClinicalTrials.gov ID
- NCT03362749
- Acronym / sponsor ID
- EAST / 201703032RIND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 5 Dec 2017 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- 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 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.
Key inclusion criteria (6 listed)
- Patients who meet all inclusion criteria will be included:
Key exclusion criteria (6 listed)
- The procedure of local ablation is not completed due to machine or patient problem
- Received treatment with an investigational agent/ procedure within 30 days prior to local ablation
- Known history of HIV infection
- Women who are pregnant
- Life expectancy is less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFA, MWA, cryo and IRElocal tumor ablation | Other | – |
Primary outcome
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
3 secondary outcomes
The effect of local tumor ablation
Time frame: up to 3 years
To observe the survival rate
Time frame: up to 3 years
To observe the progression-free survival rate
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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.
Kai-Wen Huang, M.D. Ph.D principal investigator
National Taiwan University Hospital
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 Solid Tumor Including Thyroid, Bone, Liver, Pancreas, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Oct 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Wen Huang, M.D. Ph.D (886-2-23123456 ext. 66144, skywing@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the efficacy of local tumor ablation (time frame: through study completion, an average of 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 14 Oct 2022.