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Long Term Follow-Up Study of Immuncell-LC Group and Non-Treatment Group in Hepatocellular Carcinoma Patients. (Immuncell-LC)

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ClinicalTrials.gov Identifier: NCT01890291
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation

Brief Summary:
To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular carcinoma in Korea

Condition or disease
Hepatocellular Carcinoma

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Study Type : Observational [Patient Registry]
Actual Enrollment : 162 participants
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Long Term Study of 'Immuncell-LC Groups' and 'Non-treatment Groups' in Patient Undergo Curative Resection (PEIT, Radiofrequency Ablation [RFA] or Operation) for Hepatocellular Carcinoma in Korea
Study Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Group/Cohort
Non-treatment Group
Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).
Immuncell-LC Group
Patients who were in Immuncell-LC group in phase 3 clinical trial IIC-I01(NCT00699816).



Primary Outcome Measures :
  1. To evaluate recurrence-free survival [ Time Frame: up to 3 years ]
    Radiological test should be operated by dynamic CT(using 64 cut), dynamic MRI or by angiography.


Secondary Outcome Measures :
  1. To determine the response rate to evaluate overall survival and cause specific survival and changes of Alpha feto protein (AFP) figures from baseline to the last observation date. [ Time Frame: up to 3 years ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This long term follow-UP study is observation about the Immuncell-LC Groups' and 'Non-treatment Groups' in patient undergo curative resection (PEIT, RFA or Operation) for Hepatocelluar Carcinoma in Korea.
Criteria

Inclusion Criteria:

  • Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
  • Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial.

Exclusion Criteria:

  • Patient who is incongruent to this clinical trial by sub-investigator's opinion.

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): NCT01890291


Locations
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Korea, Republic of
Seoul National Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Korea University Ansan Hospital
Seoul, Korea, Republic of, 425-707
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
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Principal Investigator: Jung Hwan Yoon, MD Seoul National University Hospital
Principal Investigator: Joon Hyeok Lee, MD Samsung Medical Center
Principal Investigator: Young-Suk Lim, MD Asan Medical Center
Principal Investigator: Tae Gin Song, MD Korea University
Principal Investigator: Jong Eun Yeon, MD Korea University Guro Hospital
Additional Information:

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Responsible Party: Green Cross Cell Corporation
ClinicalTrials.gov Identifier: NCT01890291    
Other Study ID Numbers: IIC-I02
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Keywords provided by Green Cross Cell Corporation:
Immuncell-LC, Hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases