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A Study to See if we Can Predict How Your Liver Tumor or Liver Metastases Will Respond to Trans-Arterial Embolization (TAE)

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: NCT02772575
Recruitment Status : Withdrawn
First Posted : May 13, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment
Liver Cancer Liver Metastases Procedure: Hepatic trans-arterial embolization (TAE) Device: MRI/CT scan Procedure: biopsy Other: blood draw

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES
Study Start Date : April 2016
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Group/Cohort Intervention/treatment
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.
Procedure: Hepatic trans-arterial embolization (TAE)
Device: MRI/CT scan
Procedure: biopsy
Other: blood draw



Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
tissue blood


Information from the National Library of Medicine

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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
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).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of a second active malignancy with evidence of metastatic disease

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): NCT02772575


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Etay Ziv, MD, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02772575    
Other Study ID Numbers: 16-385
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by Memorial Sloan Kettering Cancer Center:
MOLECULAR PREDICTORS
Hepatic trans-arterial embolization (TAE)
16-385
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases