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NCT06463262 · ClinicalTrials.gov registry record
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
A clinical trial of Chordoma of Spine and Chordoma of Sacrum, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- 40
- Enrollment target
- 2
- Study locations
NCT06463262: Recruiting study of Chordoma of Spine and Chordoma of Sacrum, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT06463262 is a study of Chordoma of Spine and Chordoma of Sacrum that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 40 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06463262, a study of Chordoma of Spine and Chordoma of Sacrum, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Sensitivity and specificity of combining ctDNA and radiomic features in predicting histopathologic changes at surgery defined by patients who have \<10% necrosis, the percentage of patients who are deemed "positive" by the model based on ctDNA and radiomics
Conditions Studied
Interventions
- DIAGNOSTIC_TEST ctDNA
Study Locations (2)
Maryland
- Johns Hopkins Hospital - Baltimore
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-06-14 |
| Est. Completion | 2031-07 |
What NCT06463262 shows while recruiting
NCT06463262 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 3 conditions, with Chordoma of Spine appearing as the primary indexed condition, and to 1 intervention - of which ctDNA is the first listed.
NCT06463262 reports a single indexed study location in Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06463262 about?
NCT06463262 is a clinical study titled "Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma". 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 compa...
What is the current status of trial NCT06463262?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2024-06-14. Estimated completion is 2031-07.
What conditions does trial NCT06463262 study?
This clinical trial studies the following conditions: Chordoma of Spine, Chordoma of Sacrum, Chordoma of Skull Base.
What interventions are being tested in trial NCT06463262?
The interventions under investigation include: ctDNA (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06463262?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06463262 being conducted?
This trial has 2 study locations across Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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