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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
- ClinicalTrials.gov ID
- NCT07731880
- Acronym / sponsor ID
- RG1126428
- Conditions
- Malignant Female Reproductive System Neoplasm, Metastatic Malignant Female Reproductive System Neoplasm, Unresectable Malignant Female Reproductive System Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kalyan Banda, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kalyan Banda, MD (206-606-2222, bkalyan@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.