RECRUITING

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

Conditions

Chordoma of Spine Chordoma of Skull Base Chordoma of Sacrum

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-14

Study Completion:2031-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06463262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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.

Inclusion Criteria

Exclusion 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.
* 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.

* 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.

Contacts and Locations

Study Contact

Kristin Redmond, MD, MPH

CONTACT

4106141642

kjanson3@jhmi.edu

Jasmine Brooks, BA

CONTACT

6673068335

jbrook54@jhmi.edu

Principal Investigator

Kristin Redmond, MD, MPH

PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Locations (Sites)

Johns Hopkins Hospital

Baltimore, Maryland, 212887

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Kristin Redmond, MD, MPH, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-14

Study Completion Date2031-07

Study Record Updates

Study Start Date2024-06-14

Study Completion Date2031-07

Terms related to this study

Additional Relevant MeSH Terms

Chordoma of Spine
Chordoma of Skull Base
Chordoma of Sacrum