Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
Seattle, Washington 98109
More Details
- Status
- Recruiting
- Sponsor
- Fred Hutchinson Cancer Center
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.