Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma

Conditions

• Chordoma of Sacrum
• Chordoma of Skull Base
• Chordoma of Spine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ctDNA — DIAGNOSTIC_TEST
  the effects of neoadjuvant RT, in the form of either proton therapy or SBRT, on the ctDNA

Study Details

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.

Key Dates

Start date

Jun 14, 2024

Status verified

Oct 2025

Primary completion

Jul 31, 2029

Completion

Jul 31, 2031

Study Design

Enrollment

40 participants (estimated)

Arms

• Arm: Spinal, Sacral Chordoma

Primary Outcome Measure

Sensitivity and specificity of combining ctDNA and radiomics [ Time Frame: within one week after surgery ]

Central Contacts

• Kristin Redmond, MD, MPH
  4106141642
  [email protected]
• Jasmine Brooks, BA
  6673068335
  [email protected]

Locations (2)

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