Clinical trial · Observational
Impact of a Process Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes
A Prospective Evaluation of the Impact of a Process Engineering Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes in Community-Based Obstetrics and Gynecology Settings
NCT03081455CI-TRIAL-00028979completedClinicalTrials.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)
A prospective, non-interventional study to evaluate the impact of a process engineering intervention on screening and testing outcomes for common hereditary cancer syndromes in community-based OB/GYN settings.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Cancer | Hereditary Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women meeting guidelines for genetic testing
- description
- Women who present for an OB/GYN office visit (new patient visit, well woman visit, or problem visit) and who meet guidelines for genetic diagnostic testing will provide a blood or saliva sample for genetic diagnostic testing and complete a satisfaction survey.
- interventionNames
- Diagnostic Test: Diagnostic Test
Primary outcomes (1)
- measure
- The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.
- timeFrame
- Baseline
- description
- The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.
Secondary outcomes (1)
- measure
- The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient who presents for a new patient gynecologic visit, well woman exam, or problem gynecologic visit and meets guidelines (HBOC-NCCN guidelines; Lynch syndrome-SGO/ACOG guidelines) for genetic testing * Patient who is 18 years of age or older * Able to understand informed consent and agrees to participate Exclusion Criteria: * Patient who has previously undergone BRCA1/2, Lynch syndrome genetic testing, or multi-gene, pan-cancer, or panel testing * Patient who is not pregnant * Patient who is unwilling or unable to provide informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.