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NCT07731880

Overview

NCT ID: NCT07731880
Lead Sponsor: Fred Hutchinson Cancer CenterOTHER
Official Title: Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
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
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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