Assessing the Current Quality of Life Status of Esophageal Cancer Patients Who Have Undergone Radical Chemoradiotherapy/Radiotherapy and Long-term SurvivalNCT05828875
A Multicenter, Cross-sectional Study on the Quality of Life in Long-term Survival Esophageal Cancer Patients After Radical Radiochemotherapy/Radiotherapy
An observational study of Assessing the Current Quality of Life Status of Esophageal Cancer Patients Who Have Undergone Radical Chemoradiotherapy/Radiotherapy and Long-term Survival, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a multicenter cross-sectional survey of esophageal cancer patients who underwent radical chemoradiotherapy/radiotherapy from July 2017 to July 2020 in various medical centers, and who survived without disease progression at the time of the survey. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Assessing the Current Quality of Life Status of Esophageal Cancer Patients Who Have Undergone Radical Chemoradiotherapy/Radiotherapy and Long-term Survival
- What is being tested?
- questionnaire investigation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Jul 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is<80 years old; * Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection; * Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression; * Radiotherapy dose ≥ 45Gy.
Who may be able to join
- Voluntarily accept this survey and research;
- The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is<80 years old;
- Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection;
- Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression;
- Radiotherapy dose ≥ 45Gy.
Who cannot join
- Patients who do not cooperate with this survey;
- Patients who have died at the time of investigation;
- Patients who experience tumor progression within the time frame from the end of radiotherapy to receiving this survey;
- Patients diagnosed with other malignant tumors within the time frame from the end of radiotherapy to receiving this survey;
- Patients with incorrect contact information and missing visits
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Qingsong Pang, PHD, +86-22-23340123-1121
About this study
This study is a multicenter cross-sectional survey of esophageal cancer patients who underwent radical chemoradiotherapy/radiotherapy from July 2017 to July 2020 in various medical centers, and who survived without disease progression at the time of the survey. The purpose of this study is to evaluate the current quality of life, as well as the incidence of long-term toxic side effects, nutritional status, and psychological status of esophageal cancer patients cured by radiotherapy.
- Being tested
- questionnaire investigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire investigationOther
Conduct a questionnaire survey on patients' quality of life, nutrition, and psychology
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Assessment survey
Measured: Two years after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessing the Current Quality of Life Status of Esophageal Cancer Patients Who Have Undergone Radical Chemoradiotherapy/Radiotherapy and Long-term SurvivalStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828875
- Sponsor's protocol ID
- bc2022181
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 7 Jul 2023
- Results posted
- 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 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Cross-sectional Study on the Quality of Life in Long-term Survival Esophageal Cancer Patients After Radical Radiochemotherapy/Radiotherapy
- ClinicalTrials.gov ID
- NCT05828875
- Acronym / sponsor ID
- bc2022181
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 25 Apr 2023 (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 study is a multicenter cross-sectional survey of esophageal cancer patients who underwent radical chemoradiotherapy/radiotherapy from July 2017 to July 2020 in various medical centers, and who survived without disease progression at the time of the survey. The purpose of this study is to evaluate the current quality of life, as well as the incidence of long-term toxic side effects, nutritional status, and psychological status of esophageal cancer patients cured by radiotherapy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is<80 years old; * Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection; * Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression; * Radiotherapy dose ≥ 45Gy.
Key inclusion criteria (5 listed)
- Voluntarily accept this survey and research;
- The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is<80 years old;
- Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection;
- Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression;
- Radiotherapy dose ≥ 45Gy.
Key exclusion criteria (5 listed)
- Patients who do not cooperate with this survey;
- Patients who have died at the time of investigation;
- Patients who experience tumor progression within the time frame from the end of radiotherapy to receiving this survey;
- Patients diagnosed with other malignant tumors within the time frame from the end of radiotherapy to receiving this survey;
- Patients with incorrect contact information and missing visits
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 |
|---|---|---|
| questionnaire investigationConduct a questionnaire survey on patients' quality of life, nutrition, and psychology | Other | – |
Primary outcome
Quality of Life Assessment survey
Time frame: Two years after the end of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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.
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 Assessing the Current Quality of Life Status of Esophageal Cancer Patients Who Have Undergone Radical Chemoradiotherapy/Radiotherapy and Long-term Survival, run by Tianjin Medical University Cancer Institute and 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 5 inclusion and 5 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 7 Jul 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Assessment survey (time frame: Two years after the end of radiotherapy). 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 7 Jul 2023.