NCT Number: NCT02587793
Primary Culture of Residual Specimens Obtained From Aspiration of Hepatic Tumor to Predict the Prognosis of the Patients
The aim of this project is to investigate whether the proliferative speeds of cultured cells using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging classification for the possibility of personalized treatment and prediction the outcomes in hepatocellular carcinoma (HCC) patients.
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Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Chang Gung Memorial Hospital, Kaohsiung City, Taiwan
About this study
A total of at least 150 patients will be included and followed for at least one year. The proliferative speeds of cultured cells will be classified into (a) rapid proliferation of HCC cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (CAFs), (b) rapid proliferation of CAFs alone, and (c) slow proliferation three groups. The definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day > two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day > 70% growth area of the 25 cm flask. The GraphPad Prism software version 4.03 (GraphPad Software, Inc., La Jolla, CA, USA) is applied for statistical analysis. Influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. The statistical significance is defined as P < 0.05.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients are proven to have HCC based on fine-needle aspiration of the tumor.
- Patient have residual specimens obtained from fine-needle aspiration of the tumor.
- Patients agree to participate this study after fully explanation.
Exclusion criteria
- Patients are not proven to have HCC based on fine-needle aspiration of the tumor.
- Patient do not have residual specimens obtained from fine-needle aspiration of the tumor.
- Patients do not agree to participate this study after fully explanation.
Treatment and study plan
Primary outcomes
-
survival
Time frame: one year
Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.
Secondary outcomes
-
cancer progression
Time frame: one year
Correlation between the proliferative speeds of cultured cells and HCC progression one year after aspiration of the tumor will be investigated.
Sponsors and collaborators
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
Registry information
Official study title
Kaohsiung Medical University Chung-Ho Memorial Hospital
Important dates
- Study start
- 2014
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Oct 27, 2015
- Registry last updated
- Feb 27, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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