NCT06463262招募中不适用
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of combining ctDNA and radiomics
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Sensitivity and specificity of combining ctDNA and radiomics
时间窗: 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
次要结局
- Correlate radiomic features with histopathologic and genomic features(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(within one week after surgery)
- Percent of necrotic and active tumor cells(within one week after surgery)
- Local progression free survival(3 years)
- Rate of wound healing complications(within one week after surgery)
- Relationship between ctDNA post-op and local Progression Free Survival (PFS)(3 years)
- Relationship between ctDNA post-op and Overall Survival (OS)(3 years)
- Radiographic local recurrence(within one week after surgery)
- Overall survival(3 years)
- Change in plasma ctDNA levels(within one week after surgery)
- Toxicity of neoadjuvant RT as assessed by CTCAE version 5(3 years)
研究者
研究点 (2)
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