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

NCT ID: NCT02772575

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer Liver Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Hepatic trans-arterial embolization (TAE)

Intervention Type PROCEDURE

MRI/CT scan

Intervention Type DEVICE

biopsy

Intervention Type PROCEDURE

blood draw

Intervention Type OTHER

Interventions

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Hepatic trans-arterial embolization (TAE)

Intervention Type PROCEDURE

MRI/CT scan

Intervention Type DEVICE

biopsy

Intervention Type PROCEDURE

blood draw

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etay Ziv, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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16-385

Identifier Type: -

Identifier Source: org_study_id

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