Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

Terminated

• Conditions: Hereditary Breast and Ovarian Cancer; Adnexal Mass; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation
• Interventions: Other: OVA360

• Registration Number: NCT04668521
• Lead Sponsor: Aspira Women's Health

Brief Summary

The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-04
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-16
• Status Verified: 2023-12
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 215

Inclusion Criteria

Not provided

Exclusion Criteria

• n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COHORT A	OVA360	Women with a pelvic mass, symptomatic or asymptomatic.
COHORT B	OVA360	Women diagnosed with a pelvis mass undergoing genetic testing through our commercial offering.
COHORT C	OVA360	Subject must not have an identifiable adnexal mass and may, or may not, have a family history or a known familial genetic abnormality (germ line or identified in family cancer i.e. somatic DNA mutation) associated with ovarian cancer.

Primary Outcome Measures

Name	Time	Method
OVA360	12 months	Identify the molecular key driver of Ovarian cancer and develop a diagnostic test for early Ovarian cancer detection

Trial Locations

Locations (1)

Silvana Franco; 🇺🇸 Austin, Texas, United States