Recruiting

Observational Study

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT07731880

Conditions

Malignant Female Reproductive System Neoplasm

Metastatic Malignant Female Reproductive System Neoplasm

Unresectable Malignant Female Reproductive System Neoplasm

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Malignant Female Reproductive System Neoplasm

Metastatic Malignant Female Reproductive System Neoplasm

Unresectable Malignant Female Reproductive System Neoplasm

Study ID

NCT07731880

Start date

Sep, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 ]

Central Contacts and Locations

Central contacts

Kalyan Banda, MD

206-606-2222bkalyan@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Kalyan Banda, MD

206-606-2222bkalyan@uw.edu

Principal Investigator:

Kalyan Banda, MD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Aug 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-08-06.