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

NCT ID: NCT05100342

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2027-12-31

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.

Detailed Description

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 (section 10.0) on patients referred to radiation oncology for palliative treatments. Survival prediction score based on objective data including laboratory values, visits to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment. The prediction tool assigns a score from 0-20, with 20 indicating the worst survival prognosis; the investigators have designated mortality risk groups as follows: low-risk (score 0-6), intermediate-risk (score 7-13), and high-risk (score 14-20). Patient survival and quality of life will then be monitored at 30-day, 90-day, and 365-day intervals. The study will test the hypothesis that patients with a score of >14 have a less than 20% chance of survival at 30 days.

Primary Objective:

1. To evaluate 30-day survival of patients with a score of >14 (high-risk group)

Secondary Objectives:

1. To evaluate 30-day, 90-day, and 365-day survival of patients in low-risk (score 0-6), and intermediate-risk (score 7-13) groups, and to evaluate 90-day and 365-day survival of patients in high-risk group (score >14)

2. To evaluate patient-reported quality of life at the above intervals using the validated FACIT-Pal-14© questionnaire (Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version)

Conditions

Metastatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Low-risk

Low-risk:score 0-6

Point score prediction tool for 30-day survival

Intervention Type: 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

Intermediate-risk

Intermediate-risk: score 7-13

Point score prediction tool for 30-day survival

Intervention Type: 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

High-risk:score 14-20

Point score prediction tool for 30-day survival

Intervention Type: 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

Interventions

Point score prediction tool for 30-day survival

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 at time of consent

2. Ability to provide written informed consent

3. Cancer diagnosis referred to Radiation Oncology for palliative radiation therapy

4. Patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible

5. 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

Exclusion Criteria

1. Patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted)

2. Patients who are receiving definitive/curative course of radiation therapy

3. Patients who self-report as pregnant or nursing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Naoyuki G. Saito, M.D., Ph.D.

Assistant Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naoyuki Saito, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

IU Health West

Avon, Indiana, United States

Site Status: RECRUITING

IU Health North / Schwarz Cancer Center

Carmel, Indiana, United States

Site Status: RECRUITING

Methodist Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Anders

Role: CONTACT

jemlynn@iu.edu

(317) 274-0220

Naoyuki G Saito, MD PhD

Role: CONTACT

Facility Contacts

William Byrd

Role: primary

wabyrd@iu.edu

(317) 278-6420

Matthew Buzzell

Role: primary

matabuzz@iu.edu

(317) 274-0925

Kathy Lauer

Role: primary

klauer@iuhealth.org

317-962-3172

Other Identifiers

CTO-IUSCCC-0763

Identifier Type: -

Identifier Source: org_study_id