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NCT06012318
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
trial in Esophageal Cancer in 220 participants. Status unknown.
1 August 2024
Quick facts
| Lead sponsor | Guangdong Provincial People's Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 220 |
| Start date | 10 September 2023 |
| Primary completion | 1 August 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Conditions studied
- Esophageal Cancer — all drugs for Esophageal Cancer →
- Patient-reported Outcomes — all drugs for Patient-reported Outcomes →
- Immunotherapy — all drugs for Immunotherapy →
Sponsor
Guangdong Provincial People's Hospital
Who can join
Adults 18 to 75, any sex, with Esophageal Cancer or Patient-reported Outcomes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06012318 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangdong Provincial People's Hospital
- Last refreshed: 25 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06012318.
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