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.
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
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
Patients with metastatic or unresectable rare gynecologic cancers who are undergoing SOC procedures that yield fresh tumor tissue suitable for SmartMatch functional precision medicine profiling
Cohort
Prospective
Not listed
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
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.
Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained
Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy
Implementation Feasibility: Time from live tissue collection to SmartMatch report
Implementation Feasibility: Reasons for access failure/delay (insurance denial, clinical decline, etc.)
Will document reasons for failure or delay (insurance denial, lack of trial access, toxicity concerns, clinical deterioration, patient preference)
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