Malignant Female Reproductive System NeoplasmNCT07731880
Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
An observational study of Malignant Female Reproductive System Neoplasm and Metastatic Malignant Female Reproductive System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm, Metastatic Malignant Female Reproductive System Neoplasm, Unresectable Malignant Female Reproductive System Neoplasm
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Kalyan Banda, MD, 206-606-2222, bkalyan@uw.edu
Kalyan Banda, MD
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment up to 36 months
Secondary outcomes (9)
Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained
Measured: Up to 36 months
Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy
Measured: Up to 36 months
Implementation Feasibility: Time from live tissue collection to SmartMatch report
Measured: 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)
Measured: Up to 36 months
Proportion of patients achieving growth modulation index (GMI) ≥ 1.3
Measured: Up to 36 months
Proportion of patients achieving progression-free survival on matched therapy (PFSmatched)
Measured: Up to 36 months
Proportion of patients achieving progression-free survival on the prior line of therapy (PFSpast)
Measured: Up to 36 months
Proportion of patients achieving GMI = PFSmatched / PFSpast
Measured: 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)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kalyan Banda, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731880
- Sponsor's protocol ID
- RG1126428
- Other IDs
- NCI-2026-05123, FHIRB0021265
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No