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

5. august 2026 opdateret af: Fred Hutchinson Cancer Center
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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Kalyan Banda, MD
  • Telefonnummer: 206-606-2222
  • E-mail: bkalyan@uw.edu

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Rekruttering
        • Fred Hutch/University of Washington Cancer Consortium
        • Ledende efterforsker:
          • Kalyan Banda, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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.
From enrollment up to 36 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fred Hutchinson Cancer Center

Efterforskere

  • Ledende efterforsker: Kalyan Banda, MD, Fred Hutch/University of Washington Cancer Consortium

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. juli 2029

Datoer for studieregistrering

Først indsendt

23. juli 2026

Først indsendt, der opfyldte QC-kriterier

23. juli 2026

Først opslået (Faktiske)

28. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RG1126428
  • NCI-2026-05123 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • FHIRB0021265 (Anden identifikator: Fred Hutch/University of Washington Cancer Consortium)

Plan for individuelle deltagerdata (IPD)

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