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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04239781
Other study ID # HCC treatment survey
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2020
Est. completion date July 2020

Study information

Verified date January 2020
Source Shanghai Zhongshan Hospital
Contact Huichuan Sun
Phone 0086-21-64041990
Email sun.huichuan@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a non-interventional and questionnaire survey study. The investigators try to find out patient's willingness and expectation for post-operative treatments for hepatocellular carcinoma (HCC), as well as patients' willingness to participate in clinical trials using a questionnaire. The ultimate goal is to assist physicians in clinical treatment decision, clinical research, and government health and economic decision-making, as well as to help investigators understand how to increase public awareness of the HCC and the treatment course and efficacy of HCC, and the awareness of clinical trials.


Description:

There is no world widely accepted adjuvant therapy for HCC and the guidelines from AASLD or EASL did not recommend any adjuvant therapy to prevent postoperative tumor recurrence of HCC. The goal of an adjuvant therapy is to meet the requirements of patients, which are influenced by many factors such as the strength of doctors' recommendation, economic affordability, tolerance of adverse reactions to treatment, and expectation of efficacy. Therefore, understanding patients' expectations for an adjuvant therapy after surgery will help doctors give more reasonable treatment. Participating in clinical trials is a new process of understanding and acceptance for each patient, so investigators try to understand the willingness and ideas of patients to participate in clinical trials, so as to provide more information for designing clinical trials and recruiting subjects for clinical trials.

The research was conducted through face-to-face interview, WeChat and telephone interview. For face-to-face interview and WeChat to participants, an informed consent should be signed.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date July 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female aged 18 years or older;

- Confirmed diagnosis of HCC histologically or clinically;

- The participant must have received surgical resection;

- Ability to complete the questionnaire or independently or with the help of a friend, relative, or staff member of the oncology department.

Exclusion Criteria:

- The patients that researchers consider not suitable to participate in this study.

Study Design


Locations

Country Name City State
China Shanghai Zhongshan Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary HCC patients' willingness and expectation for post-operative treatment. Use questionnaires to understand the willingness and expectation of patients for post-operative treatment of hepatocellular carcinoma, as well as their willingness to participate in clinical trials. 6 months
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