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Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

Study acronym: PRAISE
StatusActive, Not Recruiting
PhasePhase 4
Started2019-11-29
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 12, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-03-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-11→2025-06
Completion date2025-11→2025-06
Enrollment targetestimated 900→confirmed 905
Study sitesdetails revised at 1 of 1 site
2022-08-17
Study Status v4
Re-verified, no change to tracked fields
2022-03-02
Study Status, Study Design, Outcome Measures v3
Primary completion date2025-05→2025-11
Completion date2025-05→2025-11
Enrollment target2000→900
Secondary endpoints8 to 10 entries
Changes in patients' quality of life over time and the impacts of OASI Changes in patients' quality of life over time and the impacts of OASI
2021-08-05
Study Status v2
Primary completion date2026-11→2025-05
Completion date2026-11→2025-05
2020-01-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-03→2026-11
Completion date2026-03→2026-11
Start dateestimated 2019-03→confirmed 2019-11-29
Study sites0→1
2019-02-19
Original filing
This is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with "checkpoint inhibitors" in mono or combo therapy in real life. The study is based on patients reported experience validated by physician, recruited in cancer centers in France with another data collection from a French healthcare data claims database and a biological collection.
Trial Details
NCT Number NCT03849131
Lead Sponsor University Hospital, Strasbourg, France
Conditions Opportunistic Autoimmune Diseases
Enrollment 905 participants
Start Date 2019-11-29
Primary Completion 2025-06 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2025-03-12