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Recruiting NCT07731880

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

— Observational Malignant Female Reproductive System Neoplasm Metastatic Malignant Female Reproductive System Neoplasm Unresectable Malignant Female Reproductive System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Malignant Female Reproductive System Neoplasm, Metastatic Malignant Female Reproductive System Neoplasm, Unresectable Malignant Female Reproductive System Neoplasm. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

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]
Secondary outcome measures (9)
  • Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained [Time frame: Up to 36 months]
  • Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy [Time frame: Up to 36 months]
  • Implementation Feasibility: Time from live tissue collection to SmartMatch report [Time frame: Up to 36 months]
  • Implementation Feasibility: Reasons for access failure/delay (insurance denial, clinical decline, etc.) [Time frame: Up to 36 months]
  • Proportion of patients achieving growth modulation index (GMI) ≥ 1.3 [Time frame: Up to 36 months]
  • Proportion of patients achieving progression-free survival on matched therapy (PFSmatched) [Time frame: Up to 36 months]
  • Proportion of patients achieving progression-free survival on the prior line of therapy (PFSpast) [Time frame: Up to 36 months]
  • Proportion of patients achieving GMI = PFSmatched / PFSpast [Time frame: Up to 36 months]
  • Proportion of patients who begin identified treatment pathways following Precision Medicine Tumor Board (PMTB) review [Time frame: Up to 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07731880 · RG1126428 · NCI-2026-05123 · FHIRB0021265

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗