Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
NCT Number: NCT06463262
Acronym: Canon
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chordoma of Spine|Chordoma of Skull Base|Chordoma of Sacrum
Interventions: DIAGNOSTIC_TEST: ctDNA
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Canon Medical Systems, USA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-14
Completion Date: 2031-07
Locations: Johns Hopkins Hospital, Baltimore, Maryland, 212887, United States

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 Measures: Sensitivity and specificity of combining ctDNA and radiomics, 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, within one week after surgery
Secondary Outcome Measures: Percent of necrotic and active tumor cells, Percent of necrotic and active tumor cells following neoadjuvant RT using proton therapy or SBRT according to the Johns Hopkins Solid Tumor Panel Next Generation Sequencing, within one week after surgery|Change in plasma ctDNA levels, Change in plasma ctDNA levels following neoadjuvant RT for spinal chordoma and correlate changes in ctDNA levels with histopathologic changes at surgery, within one week after surgery|Correlate radiomic features with histopathologic and genomic features, Correlate radiomic features with histopathologic and genomic features in patients receiving neoadjuvant RT for spinal and sacral chordoma, within one week after surgery|Radiographic local recurrence, Radiographic local recurrence defined as evidence of progressive disease on CT/MRI in the operative site when compared to post-op imaging., within one week after surgery|Rate of wound healing complications, Rate of wound healing complications following neoadjuvant RT for spinal chordoma, within one week after surgery|Health related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QLQ-C15-PAL) questionnaire, Health related quality of life following neoadjuvant RT for spinal chordoma measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QLQ-C15-PAL) questionnaire. The scoring ranges from 0-21, with 21 being the highest quality of life., within one week after surgery|Local progression free survival, Local progression free survival following neoadjuvant RT for spinal chordoma, 3 years|Overall survival, Overall survival following neoadjuvant RT for spinal chordoma, 3 years|Relationship between ctDNA post-op and local Progression Free Survival (PFS), The relationship between circulating tumor DNA post-operatively and local PFS following neoadjuvant RT for spinal chordoma, 3 years|Relationship between ctDNA post-op and Overall Survival (OS), The relationship between circulating tumor DNA post-operatively and OS following neoadjuvant RT for spinal chordoma, 3 years|Toxicity of neoadjuvant RT as assessed by CTCAE version 5, Toxicity of neoadjuvant RT for chordoma using CTCAE version 5, 3 years