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

NCT05100342 | Recruiting DMC

• 1 other identifier: CTO-IUSCCC-0763
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Metastatic Cancer

Keywords

palliative radiation; radiation therapy

Outcome Measures

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

  From baseline to 30 days after enrollment

Secondary Outcomes (2)

• 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

  30 days, 90 days and 365 days after enrollment

• Tabulated patient-report quality of life surveys at 30 days, 90 days, and 365 days

  Baseline, 30 days, 90 days and 365 days after enrollment

Study Arms (3)

Low-risk

Low-risk:score 0-6

Diagnostic Test: Point score prediction tool for 30-day survival

Intermediate-risk

Intermediate-risk: score 7-13

Diagnostic Test: Point score prediction tool for 30-day survival

High-risk

High-risk:score 14-20

Diagnostic Test: Point score prediction tool for 30-day survival

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

High-risk; Intermediate-risk; Low-risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• 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 course of treatment will remain eligible Note: Patients who ultimately either choose to not receive radiation or not recommended to receive radiation will remain eligible
• Note: Patients who ultimately do not complete prescribed radiation will remain eligible

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

IU Health West

Avon, Indiana, 46123, United States

RECRUITING

IU Health North / Schwarz Cancer Center

Carmel, Indiana, 46032, United States

RECRUITING

Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Naoyuki Saito, MD PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Anders

CONTACT

(317) 274-0220; jemlynn@iu.edu

Naoyuki G Saito, MD PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 29, 2021
• Study Start: September 12, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (3)