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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
Recruitment Status : Not yet recruiting
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
Sponsor:
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

Tracking Information
First Submitted Date July 26, 2023
First Posted Date August 25, 2023
Last Update Posted Date August 25, 2023
Estimated Study Start Date September 10, 2023
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2023)		 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 24, 2023)		 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Official Title Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Esophageal Cancer
  • Patient-reported Outcomes
  • Immunotherapy
Intervention Not Provided
Study Groups/Cohorts
  • Monoimmunotherapy group
  • Chemoimmunotherapy group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 24, 2023)		 220
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Guibin Qiao, MD 13602749153 guibinqiao@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT06012318
Other Study ID Numbers SPRING
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party GuiBin Qiao, Guangdong Provincial People's Hospital
Original Responsible Party Same as current
Current Study Sponsor Guangdong Provincial People's Hospital
Original Study Sponsor Same as current
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
Investigators
Principal Investigator: Guibin Qiao, MD Guangdong Provincial People's Hospital
PRS Account Guangdong Provincial People's Hospital
Verification Date August 2023