Observational Study on Patients With Hepatocellular Carci... | NCT04021056

Studies
Observational Study on Patients With Hepatocellular Carcinoma (HCC)

NCT04021056

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Jul 16, 2019Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Aug 31, 2019Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Apr 23, 2019

First Submission Date that Met QC Criteria

Jul 12, 2019

First Posted Date

Jul 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2019

Last Update Posted Date

Jul 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinlin Hou, Professor, Nanfang Hospital, Southern Medical UniversityPrincipal Investigator

Lead Sponsor

Nanfang Hospital, Southern Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the overall survival rate of all HCC patients	In order to identify the potential influence factors of HCC patients survival	10 years
Evaluate the recurrence free survival rate of HCC patients after curative treatments	In order to identify the potential influence factors of tumor recurrence	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed and treated as HCC in Liver Cancer Center, Nanfang Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinlin Hou	Contact			jlhousmu@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang Hospital	Recruiting	Guangzhou	Guangdong		China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided