Clinical trial · Observational
Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
NCT07731880CI-TRIAL-00120917recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Observational - SmartMatch laboratory analysis
- description
- 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 outcomes (1)
- 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
- timeFrame
- From enrollment up to 36 months
- description
- 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.
Secondary outcomes (9)
- measure
- Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained
- timeFrame
- Up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.