Clinical trial · Interventional
Identifying and Caring for Individuals With Inherited Cancer Syndrome
Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes
NCT04494945CI-TRIAL-00117819recruitingN/AClinicalTrials.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 trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
| Breast Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Hereditary Neoplastic Syndrome | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Genetic Counseling | Other | — | UNRESOLVED |
| Genetic Testing | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Screening (genetic testing)
- description
- Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Genetic Counseling
- Other: Genetic Testing
- Other: Survey Administration
Primary outcomes (4)
- measure
- Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
- timeFrame
- Up to 5 years
- description
- Determine the costs and effectiveness, specifically Quality Adjusted Life Years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ALL COHORTS: 18 years of age or older * Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent * Retrospective COHORT A: Patients may or may not be diagnosed with cancer * Retrospective COHORT A: Patients have received genetic counseling in the past 5 years * Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome * COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent * COHORT A: Patients may or may not be diagnosed with cancer * COHORT A: Patients have received genetic counseling in the past 1 - 2 years * COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome * COHORT A: INCLUSIVE of no contact list to exclude from Cohort B * COHORT B: Creation of secure Healthy Oregon Project (HOP) app account * COHORT B: Consent to this project, either hard or electronic signature * COHORT B: Consent to the HOP repository, either hard or electronic signature * COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample * COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer * COHORT B: Must have had an encounter within past twelve months * COHORT B: Exclude Cohort A * COHORT C: Creation of secure Hop app account * COHORT C: Consent to this project, either hard or electronic signature * COHORT C: Consent to the HOP repository, either hard or electronic signature * COHORT C: Choosing to submit a DNA sample
References
Publications (0)
Data not yet available
No reference posted for this study.