NCT07731880 · Fred Hutchinson Cancer Center
Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
What this study is about
This study is being done to determine how easy it is to use the usual treatment (SOC) surgical resections or biopsy for SmartMatch analysis to determine treatment options in advanced gynecological malignancies.
View original scientific description
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.
Primary outcome measures
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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Seattle, Washington
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations