Hepatocellular CarcinomaNCT04239781
A Survey for Factors That Influence Postoperative Treatment Decision-making for Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2020to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received surgical resection for hepatocellular carcinoma or their relatives
Who may be able to join
- 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.
Who cannot join
- The patients that researchers consider not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, 200032
Huichuan Sun, 0086-21-64041990, sun.huichuan@zs-hospital.sh.cn
About this study
Official title: A Questionnaire Survey for Factors That Influence Postoperative Treatment Decision-making in Patients With Hepatocellular Carcinoma
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.
Read the detailed 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.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Chuan Sun, Shanghai Zhongshan Hospital
- Investigators
- Huichuan Sun, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239781
- Sponsor's protocol ID
- HCC treatment survey
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Questionnaire Survey for Factors That Influence Postoperative Treatment Decision-making in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04239781
- Acronym / sponsor ID
- HCC treatment survey
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received surgical resection for hepatocellular carcinoma or their relatives
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- The patients that researchers consider not suitable to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCC patients' willingness and expectation for post-operative treatment.
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huichuan Sun principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huichuan Sun (0086-21-64041990, sun.huichuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC patients' willingness and expectation for post-operative treatment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.