Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of participants for whom SmartMatch generates at least one actionable treatment recommendation that is presented at the PMTB within 4 weeks (≤ 28 days) of fresh tissue acquisition
研究概览
简要总结
This study is being done to determine how easy it is to use standard of care (SOC) surgical resections or biopsy for SmartMatch analysis to determine treatment options in advanced gynecological malignancies.
详细描述
OUTLINE: This is an observational study.
Patients undergo tissue sample collection obtained from standard of care surgical resection or biopsy for SmartMatch laboratory analysis and have their medical records reviewed on study.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically confirmed rare gynecologic malignancy, including but not limited to those listed
- •Metastatic or unresectable disease, OR disease for which additional systemic therapy is indicated
- •Fresh tumor tissue available from a SOC surgical procedure or biopsy that in the judgment of the treating team will yield adequate viable tumor for SmartMatch analysis
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate organ function to receive systemic therapy as determined by the treating oncologist (protocol does not specify thresholds because therapy is not mandated)
- •Ability to understand and willingness to sign informed consent
- •Willingness to allow data abstraction from the electronic health record for study endpoints
排除标准
- •Lack of tumor tissue suitable for SmartMatch analysis
- •Purely borderline tumors or benign ovarian/uterine neoplasms
- •Any condition that, in the opinion of the treating oncologist or PI, would interfere with receiving systemic therapy
- •Inability to provide informed consent or comply with study procedures
研究组 & 干预措施
Observational - SmartMatch laboratory analysis
Patients undergo tissue sample collection obtained from standard of care surgical resection or biopsy for SmartMatch laboratory analysis and have their medical records reviewed on study.
结局指标
主要结局
Proportion of participants for whom SmartMatch generates at least one actionable treatment recommendation that is presented at the PMTB within 4 weeks (≤ 28 days) of fresh tissue acquisition
时间窗: From enrollment up to 36 months
An actionable recommendation is defined as: 1. FDA-approved therapy for any indication or available clinical trial; 2. Predicted to have activity by SmartMatch functional precision medicine (FPM) and/or genomics; 3. Endorsed by PMTB as clinically reasonable.
次要结局
- Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained(Up to 36 months)
- Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy(Up to 36 months)
- Implementation Feasibility: Time from live tissue collection to SmartMatch report(Up to 36 months)
- Implementation Feasibility: Reasons for access failure/delay (insurance denial, clinical decline, etc.)(Up to 36 months)
- Proportion of patients achieving growth modulation index (GMI) ≥ 1.3(Up to 36 months)
- Proportion of patients achieving progression-free survival on matched therapy (PFSmatched)(Up to 36 months)
- Proportion of patients achieving progression-free survival on the prior line of therapy (PFSpast)(Up to 36 months)
- Proportion of patients achieving GMI = PFSmatched / PFSpast(Up to 36 months)
- Proportion of patients who begin identified treatment pathways following Precision Medicine Tumor Board (PMTB) review(Up to 36 months)