Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Female Reproductive System Neoplasm; Metastatic Malignant Female Reproductive System Neoplasm; Unresectable Malignant Female Reproductive System Neoplasm

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Kalyan Banda, MD; Phone Number: 206-606-2222; Email: bkalyan@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Principal Investigator: Kalyan Banda, MD
      • Contact: Kalyan Banda, MD; Phone Number: 206-606-2222; Email: bkalyan@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: FDA-approved therapy for any indication or available clinical trial;; Predicted to have activity by SmartMatch functional precision medicine (FPM) and/or genomics;; Endorsed by PMTB as clinically reasonable.	From enrollment up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	Will document reasons for failure or delay (insurance denial, lack of trial access, toxicity concerns, clinical deterioration, patient preference)	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	Proportion of patients falling into each pathway: Genomic-matched therapy implemented; Functional/organoid-matched therapy implemented; Physician's choice therapy (no matched therapy recommended, not obtainable, or declined)	Up to 36 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Kalyan Banda, MD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RG1126428; NCI-2026-05123 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); FHIRB0021265 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No