Recruiting

Personalized Biomarkers

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06463262

Conditions

Chordoma of Spine

Chordoma of Skull Base

Chordoma of Sacrum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ctDNA

Study Details

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

Study ID

NCT06463262

Start date

Jun 14, 2024

Status verified date

Oct, 2025

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Spinal, Sacral Chordoma

Interventions

ctDNA

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kristin Redmond, MD, MPH

4106141642kjanson3@jhmi.edu

Jasmine Brooks, BA

6673068335jbrook54@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 212887

Contacts

Kristin Redmond, MD

410-955-6980kjanson3@jhmi.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

James Schuster, MD, PhD

215-294-9494james.schuster@pennmedicine.upenn.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2025-10-24.