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

Part of paid clinical trials in Avon, Indiana.

Sponsor
Indiana University
Study ID
NCT05100342
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Point score prediction tool for 30-day survival — DIAGNOSTIC_TEST
    This tool requires laboratory data including white blood cell count, neutrophil-lymphocyte ratio, blood urea nitrogen, bilirubin, albumin, lactate dehydrogenase, and red cell distribution, as well as number of attendances to the emergency room in the past 100 days, the site receiving radiation therapy, and the primary cancer type. Each data point correlates with a point value, which are tallied to generate a final score. The scores range from 0-20, with 0 giving the highest chance for survival at 30 days and 20 giving the lowest chance for survival at 30 days

Study Details

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.

Key Dates

Start date
Sep 12, 2022
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
214 participants (estimated)

Arms

  • Arm: Low-risk
    Low-risk:score 0-6
  • Arm: Intermediate-risk
    Intermediate-risk: score 7-13
  • Arm: High-risk
    High-risk:score 14-20

Primary Outcome Measure

30-day survival of patients with a score of >14 (high-risk group) [ Time Frame: From baseline to 30 days after enrollment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
IU Health WestAvonIndiana46123
Todd Foster
[email protected]
317-278-2546
IU Health North / Schwarz Cancer CenterCarmelIndiana46032
Matthew Buzzell
[email protected]
317-274-0925
Methodist HospitalIndianapolisIndiana46202
Kathy Lauer
[email protected]
317-962-3172

Find similar trials in Avon, IN

By research site
IU Health West· Avon, INIU Health North / Schwarz Cancer Center· Carmel, INMethodist Hospital· Indianapolis, IN

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