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Prospective Validation of a Points Score System Predicting 30-day Survival

StatusRecruiting
PhaseNot specified
Started2022-09-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 2026 → Jul 2027
See other at-risk trials from Indiana University

Amendment history

2026-09-18
Primary completion pushed: 2026-12 → 2027-07
Completion pushed: 2027-12 → 2028-07
2026-05-05
Study Status, Study Design, Contacts/Locations v12
Enrollment increased: 114 → 214 participants
Study sitescontacts updated at 2 of 3 sites
2026-01-06
Study Status, Oversight, Contacts/Locations v11
Primary completion date2025-12→2026-12
Completion date2026-12→2027-12
Study sitescontacts updated at 1 of 3 sites
2025-06-26
Study Identification, Study Status, Contacts/Locations v10
Study sites5→3
2025-01-09
Study Identification, Study Status, Oversight v9
Primary completion date2024-12→2025-12
Completion date2025-12→2026-12
Show 8 earlier versions
2024-07-16
Study Status, Study Design, Eligibility v8
Enrollment target57→114
Eligibility criteria+168 characters
Inclusion Criteria: Age ≥ 18 at time of consent Ability to provide written informed consent Metastatic cancerCancer diagnosis referred to Radiation Oncology for palliative radiation therapy Patients, as assessed by the radiation oncologist, who presenteither with symptoms secondarychoose to cancernot that can be palliated byreceive radiation therapy or not recommended to receive radiation therapy will remain eligible Those patients who undergo a course of palliative radiation therapy, it is not the requirement of this study to complete that course of treatment. Those who prematurely end their [...] [...]
2023-06-29
Study Status, Contacts/Locations v7
Study sites4→5
2023-06-26
Study Status, Contacts/Locations v6
Study sites5→4
2023-03-21
Study Status v5
Start date2022-07-20→2022-09-12
2022-08-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-08→confirmed 2022-07-20
Study sitesdetails revised at 5 of 5 sites
2022-06-07
Study Status v3
Start date2022-04→2022-08
2022-02-01
Study Status v2
Start date2021-12→2022-04
2021-11-02
Study Status, Study Description v1
Start date2021-11→2021-12
Study description+15 characters
[...] from 0-20, with 20 indicating the worst survival prognosis; wethe investigators have designated mortality risk groups as follows: low-risk [...]
2021-10-18
Original filing
This is a one-stage single-arm phase II clinical trial designed to prospectively test the survival prediction tool as developed by Lee et al on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, attendance to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment.
Trial Details
NCT Number NCT05100342
Lead Sponsor Indiana University
Conditions Metastatic Cancer
Enrollment 214 participants
Start Date 2022-09-12
Primary Completion 2027-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-17