OVA360: Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

• Sponsor: Aspira Women's Health (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04668521
• Collaborator: (none)
• Enrollment: 1,200
• Location: 1
• Anticipated Duration (Months): 55.9
• Patients Per Site Per Month: 21.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adnexal Mass; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation; Hereditary Breast and Ovarian Cancer	Other: OVA360

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
• Actual Study Start Date: May 4, 2020
• Anticipated Primary Completion Date: Oct 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
COHORT A Women with a pelvic mass, symptomatic or asymptomatic.	Other: OVA360; Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
COHORT B Women diagnosed with a pelvis mass undergoing genetic testing through our commercial offering.	Other: OVA360; Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
COHORT C 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.	Other: OVA360; Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

Outcome Measures

Primary Outcome Measures

1. OVA360 [12 months]

   Identify the molecular key driver of Ovarian cancer and develop a diagnostic test for early Ovarian cancer detection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Silvana Franco	Austin	Texas	United States	78738

Sponsors and Collaborators

• Aspira Women's Health

Investigators

• Principal Investigator: Lesley Northrop, PhD, FACMG, Aspira Women's Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aspira Women's Health
• ClinicalTrials.gov Identifier: NCT04668521
• Other Study ID Numbers: 05-2019
• First Posted: Dec 16, 2020
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hereditary Breast and Ovarian Cancer Syndrome

Study Results

No Results Posted as of Jul 21, 2022