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出境医 / 临床实验 / Observational Study on Patients With Hepatocellular Carcinoma (HCC)
Observational Study on Patients With Hepatocellular Carcinoma (HCC)
Study Description
Brief Summary:
This is an ongoing, longitudinal, single centre, observational, retro-prospective clinical cohort study of patients with HCC in usual clinical practice. All the HCC patients diagnosed and treated in Liver Cancer Center, Nanfang Hospital are consecutively collected and followed up.
| Condition or disease | Intervention/treatment |
|---|---|
| Hepatocellular Carcinoma | Other: No intervention |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 3000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | Observational Study on Patients With Hepatocellular Carcinoma (HCC) |
| Actual Study Start Date : | January 1, 2011 |
| Estimated Primary Completion Date : | August 31, 2019 |
| Estimated Study Completion Date : | December 31, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Evaluate the overall survival rate of all HCC patients [ Time Frame: 10 years ]In order to identify the potential influence factors of HCC patients survival
- Evaluate the recurrence free survival rate of HCC patients after curative treatments [ Time Frame: 10 years ]In order to identify the potential influence factors of tumor recurrence
Eligibility Criteria
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed and treated as HCC in Liver Cancer Center, Nanfang Hospital
Criteria
Inclusion Criteria:
- Clinical diagnosis of HCC;
- Age ≥ 16 years;
- Received treatment targeting for HCC at least once, including operation, ablation, TACE, sorafenib, radiotherapy, chemotherapy, etc;
- Good compliance with clinical treatment.
Exclusion Criteria:
- Diagnosed as other pathological types such as cholangiocarcinoma, or mixed liver cancer;
- Received only traditional Chinese medicine or symptomatic supportive treatment; (3) survival time ≤ 7 days;
- HCC diagnosed after liver transplantation;
- Poor compliance or important data deficient.
Contacts and Locations
Contacts
| Contact: Jinlin Hou | jlhousmu@163.com |
Locations
| China, Guangdong | |
| Nanfang Hospital | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Jinlin Hou jlhousmu@163.com | |
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 23, 2019 | ||||
| First Posted Date | July 16, 2019 | ||||
| Last Update Posted Date | July 16, 2019 | ||||
| Actual Study Start Date | January 1, 2011 | ||||
| Estimated Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Observational Study on Patients With Hepatocellular Carcinoma (HCC) | ||||
| Official Title | Observational Study on Patients With Hepatocellular Carcinoma (HCC) | ||||
| Brief Summary | This is an ongoing, longitudinal, single centre, observational, retro-prospective clinical cohort study of patients with HCC in usual clinical practice. All the HCC patients diagnosed and treated in Liver Cancer Center, Nanfang Hospital are consecutively collected and followed up. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients diagnosed and treated as HCC in Liver Cancer Center, Nanfang Hospital | ||||
| Condition | Hepatocellular Carcinoma | ||||
| Intervention | Other: No intervention | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
3000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2022 | ||||
| Estimated Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 16 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04021056 | ||||
| Other Study ID Numbers | NFHCC-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Jinlin Hou, Nanfang Hospital of Southern Medical University | ||||
| Study Sponsor | Nanfang Hospital of Southern Medical University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Nanfang Hospital of Southern Medical University | ||||
| Verification Date | July 2019 | ||||
