Chordoma of SpineCanonNCT06463262
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
An observational study of Chordoma of Spine and Chordoma of Skull Base, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordoma of Spine, Chordoma of Skull Base, Chordoma of Sacrum
- What is being tested?
- ctDNA
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2024to Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 212887
Kristin Redmond, MD, 410-955-6980, kjanson3@jhmi.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
James Schuster, MD, PhD, 215-294-9494, james.schuster@pennmedicine.upenn.edu
About this study
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.
- Being tested
- ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNADiagnostic test
the effects of neoadjuvant RT, in the form of either proton therapy or SBRT, on the ctDNA
| Study group | Role | What they receive |
|---|---|---|
| Spinal, Sacral Chordoma | Not described Receives: Diagnostic Test: ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within one week after surgery
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: within one week after surgery
Rate of wound healing complications
Rate of wound healing complications following neoadjuvant RT for spinal chordoma
Measured: 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.
Measured: within one week after surgery
Local progression free survival
Local progression free survival following neoadjuvant RT for spinal chordoma
Measured: 3 years
Overall survival
Overall survival following neoadjuvant RT for spinal chordoma
Measured: 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
Measured: 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
Measured: 3 years
Toxicity of neoadjuvant RT as assessed by CTCAE version 5
Toxicity of neoadjuvant RT for chordoma using CTCAE version 5
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start14 Jun 2024
- Primary completionJul 2029 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chordoma of SpineStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Kristin Redmond, MD, MPH, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463262
- Sponsor's protocol ID
- J2317
- Other IDs
- IRB00291203
- Acronym
- Canon
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
- ClinicalTrials.gov ID
- NCT06463262
- Acronym / sponsor ID
- Canon / J2317
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal, Sacral Chordoma | – | Diagnostic Test: ctDNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNAthe effects of neoadjuvant RT, in the form of either proton therapy or SBRT, on the ctDNA | Diagnostic test | Spinal, Sacral Chordoma |
Primary outcome
Sensitivity and specificity of combining ctDNA and radiomics
Time frame: within one week after surgery
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
11 secondary outcomes
Percent of necrotic and active tumor cells
Time frame: within one week after surgery
Change in plasma ctDNA levels
Time frame: within one week after surgery
Correlate radiomic features with histopathologic and genomic features
Time frame: within one week after surgery
Radiographic local recurrence
Time frame: within one week after surgery
Rate of wound healing complications
Time frame: 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
Time frame: within one week after surgery
Local progression free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Relationship between ctDNA post-op and local Progression Free Survival (PFS)
Time frame: 3 years
Relationship between ctDNA post-op and Overall Survival (OS)
Time frame: 3 years
Toxicity of neoadjuvant RT as assessed by CTCAE version 5
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Chordoma of Spine
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Redmond, MD, MPH principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chordoma of Spine and Chordoma of Skull Base, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Redmond, MD, MPH (4106141642, kjanson3@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of combining ctDNA and radiomics (time frame: within one week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.