Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection (OVA360)

Aspira Women's Health

Status: Terminated

Conditions: Germline BRCA2 Gene Mutation; Germline BRCA1 Gene Mutation; Hereditary Breast and Ovarian Cancer; Adnexal Mass

Treatments: Other: OVA360

Study type: Observational

Funder types: Industry

Identifiers

NCT04668521

05-2019

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

• Female subject
• 18 years of age or older

Cohort A specific inclusion criteria:

• Diagnosed with a pelvic mass

Cohort B specific inclusion criteria:

• Diagnosed with a pelvic mass
• Undergoing genetic testing through our commercial offering

Cohort C specific inclusion criteria:

• 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.

Exclusion Criteria:

• n/a

Trial design

215 participants in 3 patient groups

COHORT A

Description:

Women with a pelvic mass, symptomatic or asymptomatic.

Treatment:

Other: OVA360

COHORT B

Description:

Women diagnosed with a pelvis mass undergoing genetic testing through our commercial offering.

Treatment:

Other: OVA360

COHORT C

Description:

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.

Treatment:

Other: OVA360