Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
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| ClinicalTrials.gov Identifier: NCT06012318 |
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Recruitment Status :
Not yet recruiting
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
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Sponsor:
Guangdong Provincial People's Hospital
Collaborators:
First Affiliated Hospital of Shantou University Medical College
The General Hospital of Southern Theater Command
The First Affiliated Hospital of Guangdong Pharmaceutical University
Shantou Central Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Shenzhen Second People's Hospital
Longgang District Central Hospital of Shenzhen
Shenzhen Third People's Hospital
Shenzhen People's Hospital
Sichuan Cancer Hospital and Research Institute
Guangzhou Panyu Central Hospital
Information provided by (Responsible Party):
GuiBin Qiao, Guangdong Provincial People's Hospital
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Brief Summary:
Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer. Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy and radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients' functional status during treatment. However, the spectrum of symptoms in esophageal cancer patients receiving immunotherapy is uncertain, and there are no studies applying the symptom bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective study, the investigators aimed to preliminarily screen for symptoms associated with immunotherapy for esophageal cancer through a systematic literature review and expert evaluation, and build a symptom item bank for esophageal cancer patients receiving immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were collected prospectively. The distribution and severity of the symptoms, as well as the trajectory of symptom change were further analyzed to demonstrate the validity and reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal cancer patients receiving immunotherapy and provide a foundation for assessing the specific symptom burden in patients with esophageal cancer receiving immunotherapy regimens.
| Condition or disease |
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| Esophageal Cancer Patient-reported Outcomes Immunotherapy |
| Study Type : | Observational |
| Estimated Enrollment : | 220 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING) |
| Estimated Study Start Date : | September 10, 2023 |
| Estimated Primary Completion Date : | August 1, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
|---|
| Monoimmunotherapy group |
| Chemoimmunotherapy group |
Primary Outcome Measures :
- Prevalence and severity of adverse symptoms [ Time Frame: Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months. ]Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy
Secondary Outcome Measures :
- Trajectory of adverse symptoms [ Time Frame: Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months. ]Trajectory of adverse symptoms in esophageal cancer patients treated with immunotherapy
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The target population of the study is patients with esophageal cancer who have received or are receiving immunotherapy-based regimens in various stages, including resectable, locally advanced, and advanced stages.
Criteria
Inclusion Criteria:
- Pathologically confirmed resectable, locally advanced, advanced metastatic esophageal cancer
- Having received or undergoing an immunotherapy-based treatment regimen
- Age 18-75 years
- ECOG PS of 0-2
- Adequate organ function
- Life expectancy > 6 months
- Participants are fully informed about the whole study and are willing to sign the informed consent
Exclusion Criteria:
- Absence of immunotherapy regimen, or recieving radiotherapy.
- Presence of primary tumours elsewhere, such as gastric cancer, lung cancer or cervical cancer
- Severe organ function deterioration and intolerance to immunotherapy
- Pregnant or breast-feeding women
- Previous autoimmune disease
- Any other conditions that may affect patients' safety and compliance
- Psychological, family, social and other factors leading to inability to inform consent
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06012318
Contacts
| Contact: Guibin Qiao, MD | 13602749153 | guibinqiao@126.com |
Locations
| China, Guangdong | |
| Guangdong Provincial People's Hospital | |
| Guangzhou, Guangdong, China, 510080 | |
Sponsors and Collaborators
Guangdong Provincial People's Hospital
First Affiliated Hospital of Shantou University Medical College
The General Hospital of Southern Theater Command
The First Affiliated Hospital of Guangdong Pharmaceutical University
Shantou Central Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Shenzhen Second People's Hospital
Longgang District Central Hospital of Shenzhen
Shenzhen Third People's Hospital
Shenzhen People's Hospital
Sichuan Cancer Hospital and Research Institute
Guangzhou Panyu Central Hospital
Investigators
| Principal Investigator: | Guibin Qiao, MD | Guangdong Provincial People's Hospital |
| Responsible Party: | GuiBin Qiao, Professor of Medicine, Guangdong Provincial People's Hospital |
| ClinicalTrials.gov Identifier: | NCT06012318 |
| Other Study ID Numbers: |
SPRING |
| First Posted: | August 25, 2023 Key Record Dates |
| Last Update Posted: | August 25, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by GuiBin Qiao, Guangdong Provincial People's Hospital:
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Esophageal Cancer Immunotherapy Patient-reported Outcomes Symptom item bank |
Additional relevant MeSH terms:
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Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |