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Trial Title:
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
NCT ID:
NCT06012318
Condition:
Esophageal Cancer
Patient-reported Outcomes
Immunotherapy
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Esophageal Cancer
Immunotherapy
Patient-reported Outcomes
Symptom item bank
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Start date:
September 10, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Shantou University Medical College
Agency class:
Other
Collaborator:
Agency:
The General Hospital of Southern Theater Command
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Guangdong Pharmaceutical University
Agency class:
Other
Collaborator:
Agency:
Shantou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital of Shantou University Medical College
Agency class:
Other
Collaborator:
Agency:
Shenzhen Second People's Hospital
Agency class:
Other
Collaborator:
Agency:
Longgang District Central Hospital of Shenzhen
Agency class:
Other
Collaborator:
Agency:
Shenzhen Third People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shenzhen People's Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Guangzhou Panyu Central Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06012318
