Prospective Validation of a Points Score System Predicting 30-day Survival
ConditionMetastatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 at time of consent
Ability to provide written informed consent
Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy
Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible
Disqualifiers
Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)
Patients who are receiving definitive/curative course of radiation therapy
Patients who self-report as pregnant or nursing
Trial population
Potential patients will be identified and recruited per the recommendation of the consulting radiation oncologist at IUSCCC, IUH Methodist Hospital, Schwarz Cancer Center and IU West hospital.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Point score prediction tool for 30-day survival
Diagnostic testThis 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
Treatment groups
214 Participants
are divided into 3 treatment groupsGroup A: Low-risk1 intervention
Group B: Intermediate-risk1 intervention
Group C: High-risk1 intervention
Trial outcomes
Primary outcomes
1
30-day survival of patients with a score of >14 (high-risk group)
The percentage of patients with a score of \>14 who are living at 30 days following enrollment
Time frame
From baseline to 30 days after enrollmentSecondary outcomes
1
The percentage of patients in each risk group (low, intermediate, and high) who are living at 30 days, 90 days, and 365 days following enrollment
Review of medical records.
Time frame
30 days, 90 days and 365 days after enrollment2
Tabulated patient-report quality of life surveys at 30 days, 90 days, and 365 days
Using the FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version
Time frame
Baseline, 30 days, 90 days and 365 days after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov