NeoplasmsNCT04996732
Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Single-institutional Cancer Registry
An observational study of Neoplasms and Survival, run by Fudan University at 1 site in China.
Trial summary
Real-world studies on long-term prognosis in patients who underwent anti-tumor treatments during hospitalization from a hospital-based cancer registry in china. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- hospitalization
- Type of treatment
- Surgery or procedure
- How many people
- 500,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2008to 31 Dec 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.
Who may be able to join
- All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.
Who cannot join
- Patients who have not been treated during hospitalization;
- Patients with non-malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Ying Zheng, Dr., +8618121299522, zhengying@fudan.edu.cn
About this study
Official title: Studies on Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Fudan University Shanghai Cancer Center Registry（FUCaRe）
Real-world studies on long-term prognosis in patients who underwent anti-tumor treatments during hospitalization from a hospital-based cancer registry in china.
Read the detailed description
This is a single-center continuous enrollment cohort study. The overall survival and disease-free survival of patients with malignant tumors in the target tumor hospital undergoing surgery, radiotherapy, chemotherapy, and immunotherapy were observed. Follow-up methods include medical records review, telephone call interview, and data linkage to the related provincial death certificate registries. This study will provide real world data-sets for researches on long-term survival and prognosis of cancer patients, and expend exploration on the cancer survival determinants both from clinical and social-economic prospective.
- Conditions
- Neoplasms, Survival, Surgery, Radiotherapy, Drug Therapy
- Being tested
- hospitalization
- Keywords
- Cancer, Survivorship
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospitalizationProcedure or surgery
Including various treatments such as surgery, radiotherapy, chemotherapy and immunotherapy during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| All Cancers | subgroups according to cancer sites Receives: Procedure: hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Death from any cause
Measured: 15 years
Secondary outcomes (1)
Disease-free survival
the time from treatment to recurrence of cancer, second primary cancer or death
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Jan 2008
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zheng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996732
- Sponsor's protocol ID
- YF-2021-01
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Fudan University Shanghai Cancer Center Registry（FUCaRe）
- ClinicalTrials.gov ID
- NCT04996732
- Acronym / sponsor ID
- YF-2021-01
- Conditions
- Neoplasms, Survival, Surgery, Radiotherapy, Drug Therapy
- Keywords
- Cancer, Survivorship
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 9 Aug 2021 (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.
Real-world studies on long-term prognosis in patients who underwent anti-tumor treatments during hospitalization from a hospital-based cancer registry in china.
Detailed description
This is a single-center continuous enrollment cohort study. The overall survival and disease-free survival of patients with malignant tumors in the target tumor hospital undergoing surgery, radiotherapy, chemotherapy, and immunotherapy were observed. Follow-up methods include medical records review, telephone call interview, and data linkage to the related provincial death certificate registries. This study will provide real world data-sets for researches on long-term survival and prognosis of cancer patients, and expend exploration on the cancer survival determinants both from clinical and social-economic prospective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Cancers | – | Procedure: hospitalizationsubgroups according to cancer sites |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.
Key inclusion criteria (1 listed)
- All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.
Key exclusion criteria (2 listed)
- Patients who have not been treated during hospitalization;
- Patients with non-malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hospitalizationIncluding various treatments such as surgery, radiotherapy, chemotherapy and immunotherapy during hospitalization | Procedure or surgery | All Cancers |
Primary outcome
Overall survival
Time frame: 15 years
Death from any cause
1 secondary outcome
Disease-free survival
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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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.
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 Neoplasms and Survival, run by Fudan University 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Aug 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zheng, Dr. (+8618121299522, zhengying@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 15 years). 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 9 Aug 2021.