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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Kristin Redmond, MD, MPH
kjanson3@jhmi.edu
4106141642
Backup
Jasmine Brooks, BA
jbrook54@jhmi.edu
6673068335
Time Frame
Start Date: 2024-06-14
Estimated Completion Date: 2031-07
Participants
Target number of participants: 40
Treatments
Spinal, Sacral Chordoma
Related Therapeutic Areas
Sponsors
Collaborators: Canon Medical Systems, USA
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov