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

NCT07731880 | Recruiting

• 3 other identifiers: RG1126428NCI-2026-05123FHIRB0021265
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Female Reproductive System Neoplasm; Metastatic Malignant Female Reproductive System Neoplasm; Unresectable Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment up to 36 months

Secondary Outcomes (9)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

Study Officials

• Kalyan Banda, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kalyan Banda, MD

CONTACT

206-606-2222; bkalyan@uw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)