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NCT02772575 Clinical Trial

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

Liver Cancer Clinical Trial

Official title:
A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02772575
Other study ID # 16-385
Secondary ID
Status Withdrawn
Phase N/A
First received May 12, 2016
Last updated January 30, 2017
Start date April 2016

Study information
Verified date January 2017
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hepatic trans-arterial embolization (TAE)

Device:
• MRI/CT scan

Procedure:
• biopsy

Other:
• blood draw

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 within 4 weeks
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