Actively Recruiting
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-10-24
40
Participants Needed
2
Research Sites
367 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
C
Canon Medical Systems, USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study the investigators will study the effects of neoadjuvant radiation therapy (RT), in the form of either proton therapy or stereotactic body radiation therapy (SBRT), on the Circulating tumor DNA (ctDNA), radiographic changes and radiomics, and the validity of these findings will be compared using the current gold standard- pathologic findings. The purpose of this work is to explore whether the biomarkers may be used diagnostically to better understand radiographic changes following RT. The investigators hypothesize that ctDNA levels in combination with imaging biomarkers identified through radiomics will be a sensitive and specific tool for predicting histopathologic response to RT.
CONDITIONS
Official Title
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed chordoma of the skull base, spine, or sacrum (including coccyx lesions)
- Radiographic evidence of spinal or sacral chordoma from CT or MRI (other imaging with approval)
- Neoadjuvant proton therapy or SBRT deemed appropriate by treating physician
- Planned surgical resection with curative intent
- Karnofsky Performance Score of 40 or higher
- Negative pregnancy test for women of childbearing potential before treatment
- Willingness to use adequate contraception during study and for 12 weeks after
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior radiation or radiosurgery to the involved spine level
- Presence of metastatic disease
- Prior malignancies except treated basal or squamous cell skin cancer, cervical carcinoma in situ, or cancers with at least 1 year disease-free
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
- Pregnant women
- Women of childbearing potential unwilling or unable to use acceptable birth control during study and 12 weeks after
- Male subjects unwilling to use effective contraception during study and 12 weeks after
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Trial Site Locations
Total: 2 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 212887
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Kristin Redmond, MD, MPH
CONTACT
J
Jasmine Brooks, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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