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

NCT06463262 | Recruiting

• 2 other identifiers: J2317IRB00291203
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chordoma of Spine; Chordoma of Skull Base; Chordoma of Sacrum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Percent of necrotic and active tumor cells

  within one week after surgery

• Change in plasma ctDNA levels

  within one week after surgery

• Correlate radiomic features with histopathologic and genomic features

  within one week after surgery

• Radiographic local recurrence

  within one week after surgery

• Rate of wound healing complications

  within one week after surgery

Study Arms (1)

Spinal, Sacral Chordoma

Diagnostic Test: ctDNA

Interventions

ctDNA DIAGNOSTIC_TEST

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

Spinal, Sacral Chordoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants who are clinical patients of the PI or co-investigators may be identified during chart review in advance of a routine clinic visit or during a routine clinic visit with a provider. Patients who are enrolled in IRB: IRB00075499 (PI: Dr. Chetan Bettagowda) may be eligible for this trial as well. Once identified as a potential study participant, the study team for this ctDNA study would have to confirm eligibility as for any potential participant. In addition, potential participants may contact the study team directly. Some of these potential participants may also be identified during the multidisciplinary clinic as part of the standard clinic case review process.

You may qualify if:

• Age ≥18 years
• Histologically proven chordoma of the skull base, spine, or sacrum (coccyx lesions are eligible).
• Radiographic evidence of spinal sacral chordoma is required and may be obtained from computed tomography imaging and/or magnetic resonance imaging. Other studies may be used with principal investigator approval.
• Note: Patients enrolled in Dr. Chetan Bettegowda's J1576 study, (IRB00075499) may be considered eligible for this trial. The J1576 study enrolls patients who have been diagnosed with Chordoma. Prior to enrollment, all patients must be consented specifically for participation in this Chordoma study (IRB00291203).
• Treating physician must deem that neoadjuvant proton therapy or SBRT is appropriate treatment for the chordoma.
• Surgical resection with curative intent must be planned.
• The patient must have a Karnofsky Performance Score of 40 or greater.
• If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 12 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior radiation or radiosurgery to the involved level of the spine.
• Patients with metastatic disease will be excluded.
• Prior malignancies are excluded except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 1 year.
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
• Pregnant women are excluded. Women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Canon Medical Systems, USA: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 212887, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Kristin Redmond, MD, MPH

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Redmond, MD, MPH

CONTACT

4106141642; kjanson3@jhmi.edu

Jasmine Brooks, BA

CONTACT

6673068335; jbrook54@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2031
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (2)