UNC Metastatic Cancer Radiation Therapy Registry

The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
        • Contact:
        • Principal Investigator:
          • Shivani Sud, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects with metastatic cancer receiving palliative radiation therapy at the University of North Carolina Chapel Hill.

Description

Inclusion Criteria:

Written informed consent was obtained to participate in the study and HIPAA

Authorization for release of personal health information. Ability to understand and willingness to sign informed consent

Diagnosed with or is suspected to have metastatic cancer.

Age ≥ 18 years at the time of consent.

Evaluated to receive radiation therapy as part of their standard-of-care treatment plan.

Exclusion Criteria:

All participants must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

Any serious medical or psychiatric disorder that would interfere with the participant's ability to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Palliative radiation therapy
Subjects who are with metastatic cancer receive palliative radiation therapy.
Subjects with metastatic cancer receive radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Data
Time Frame: Up to 1 month
Clinical data and radiological assessments from participants with metastatic cancer receiving radiation therapy as a part of the standard of care will be collected.
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcomes (PRO)
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Patient reported outcomes (PRO) from participants will be collected at different time points.
Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shivani Sud, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2024

Primary Completion (Estimated)

May 1, 2033

Study Completion (Estimated)

May 1, 2033

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Radiation therapy

Subscribe