Liver CancerNCT02772575
A Study to See if we Can Predict How Your Liver Tumor or Liver Metastases Will Respond to Trans-Arterial Embolization (TAE)
An observational study of Liver Cancer and Liver Metastases, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the hereditary material in humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Metastases
- What is being tested?
- Hepatic trans-arterial embolization (TAE), MRI/CT scan and biopsy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2017
- 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: Potential research subjects will be identified by a member of the patient's treatment team, listed protocol investigators, or Interventional Radiology research team at Memorial Sloan Kettering Cancer Center (MSKCC).
Who may be able to join
- Histopathologic evidence of primary liver cancer or liver metastases
- Indication of TAE for the treatment of liver tumor
- Age ≥ 18 years
- Available tissue with adequate tissue for analysis, verified by a pathologist
Who cannot join
- History of a second active malignancy with evidence of metastatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES
The purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the hereditary material in humans. Identifying a gene that can predict how liver tumors will respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.
- Conditions
- Liver Cancer, Liver Metastases
- Being tested
- Hepatic trans-arterial embolization (TAE), MRI/CT scan, biopsy, blood draw
- Keywords
- MOLECULAR PREDICTORS, Hepatic trans-arterial embolization (TAE), 16-385
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic trans-arterial embolization (TAE)Procedure or surgery
MRI/CT scanDevice
biopsyProcedure or surgery
blood drawOther
| Study group | Role | What they receive |
|---|---|---|
| patients with primary liver or liver metastases | A biopsy will be performed as standard of care either at time of Hepatic trans-arterial embolization (TAE) or within 4 months prior to TAE. TAE is a standard of care procedure. Within 8 weeks of TAE, patient will have a clinic visit which will include medical history, physical examination, vital signs, EKG (if one is not available), and ECOG assessment. Additionally a dedicated liver CT or MR will be obtained as well as standard of care labs. IMPACT blood test will be performed at the time of any of the standard of care labs. As IMPACT platform at MSKCC continually evolves to include more genes, we will use the platform available at the time of initiation of the protocol, therefore all patients will be subjected to the same platform. RNA-seq has been demonstrated to be superior in detecting low abundance transcripts, demonstrating a broader dynamic range, and detecting different isoforms and genetic variants. Receives: Procedure: Hepatic trans-arterial embolization (TAE); Device: MRI/CT scan; Procedure: biopsy; Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
response
Response will be categorized using standard mRECIST criteria. Tumor response will be catalogued as follows:
Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Stable Disease (SD): Any cases that do not qualify for either partial response or progressive disease. Progressive Disease (PD): An increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the of viable (enhancing) target lesions recorded since treatment started.
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etay Ziv, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772575
- Sponsor's protocol ID
- 16-385
- Status last verified
- Jan 2017
- First submitted
- 12 May 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES
- ClinicalTrials.gov ID
- NCT02772575
- Acronym / sponsor ID
- 16-385
- Conditions
- Liver Cancer, Liver Metastases
- Keywords
- MOLECULAR PREDICTORS, Hepatic trans-arterial embolization (TAE), 16-385
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 13 May 2016 (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.
The purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the hereditary material in humans. Identifying a gene that can predict how liver tumors will respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with primary liver or liver metastases | – | Procedure: Hepatic trans-arterial embolization (TAE), Device: MRI/CT scan, Procedure: biopsy, Other: blood drawA biopsy will be performed as standard of care either at time of Hepatic trans-arterial embolization (TAE) or within 4 months prior to TAE. TAE is a standard of care procedure. Within 8 weeks of TAE, patient will have a clinic visit which will include medical history, physical examination, vital signs, EKG (if one is not available), and ECOG assessment. Additionally a dedicated liver CT or MR will be obtained as well as standard of care labs. IMPACT blood test will be performed at the time of any of the standard of care labs. As IMPACT platform at MSKCC continually evolves to include more genes, we will use the platform available at the time of initiation of the protocol, therefore all patients will be subjected to the same platform. RNA-seq has been demonstrated to be superior in detecting low abundance transcripts, demonstrating a broader dynamic range, and detecting different isoforms and genetic variants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, listed protocol investigators, or Interventional Radiology research team at Memorial Sloan Kettering Cancer Center (MSKCC).
Key inclusion criteria (4 listed)
- Histopathologic evidence of primary liver cancer or liver metastases
- Indication of TAE for the treatment of liver tumor
- Age ≥ 18 years
- Available tissue with adequate tissue for analysis, verified by a pathologist
Key exclusion criteria (1 listed)
- History of a second active malignancy with evidence of metastatic disease
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 |
|---|---|---|
| Hepatic trans-arterial embolization (TAE) | Procedure or surgery | patients with primary liver or liver metastases |
| MRI/CT scan | Device | patients with primary liver or liver metastases |
| biopsy | Procedure or surgery | patients with primary liver or liver metastases |
| blood draw | Other | patients with primary liver or liver metastases |
Primary outcome
response
Time frame: within 4 weeks
Response will be categorized using standard mRECIST criteria. Tumor response will be catalogued as follows: Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. Stable Disease (SD): Any cases that do not qualify for either partial response or progressive disease. Progressive Disease (PD): An increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the of viable (enhancing) target lesions recorded since treatment started.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Etay Ziv, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 Liver Cancer and Liver Metastases, run by Memorial Sloan Kettering Cancer Center 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 1 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: withdrawn, as of the sponsor's last update on 31 Jan 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
response (time frame: within 4 weeks). 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 31 Jan 2017.