Can a simple blood test predict radiation success in rare spine tumors?
NCT ID NCT06463262
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether changes in tumor DNA found in the blood and special imaging scans can predict how well chordoma tumors respond to radiation therapy given before surgery. About 40 adults with chordoma of the spine, skull base, or sacrum will receive proton therapy or stereotactic body radiation therapy. The goal is to see if these markers can replace the current method of checking tumor response after surgery, making treatment monitoring less invasive.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 212887, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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