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NCT Number: NCT07731880

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location contact

Kalyan Banda, MD

CONTACT

[email protected]

206-606-2222

Kalyan Banda, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: From enrollment up to 36 months

    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.

Secondary outcomes

  1. Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained

    Time frame: Up to 36 months

  2. Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy

    Time frame: Up to 36 months

  3. Implementation Feasibility: Time from live tissue collection to SmartMatch report

    Time frame: Up to 36 months

  4. Implementation Feasibility: Reasons for access failure/delay (insurance denial, clinical decline, etc.)

    Time frame: Up to 36 months

    Will document reasons for failure or delay (insurance denial, lack of trial access, toxicity concerns, clinical deterioration, patient preference)

  5. Proportion of patients achieving growth modulation index (GMI) ≥ 1.3

    Time frame: Up to 36 months

  6. Proportion of patients achieving progression-free survival on matched therapy (PFSmatched)

    Time frame: Up to 36 months

  7. Proportion of patients achieving progression-free survival on the prior line of therapy (PFSpast)

    Time frame: Up to 36 months

  8. Proportion of patients achieving GMI = PFSmatched / PFSpast

    Time frame: Up to 36 months

  9. Proportion of patients who begin identified treatment pathways following Precision Medicine Tumor Board (PMTB) review

    Time frame: Up to 36 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Kalyan Banda, MD

CONTACT

[email protected]

206-606-2222

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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