Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

NCT04668521 | Terminated

• 1 other identifier: 05-2019
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• OVA360

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

  12 months

Study Arms (3)

COHORT A

Women with a pelvic mass, symptomatic or asymptomatic.

Other: OVA360

COHORT B

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

Other: OVA360

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

Interventions

OVA360 OTHER

Multifactorial Risk Assessment for Breast \& Ovarian Cancer Risk Detection

COHORT A; COHORT B; COHORT C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with or without a pelvic mass.

You may qualify if:

• Female subject
• years of age or older
• Diagnosed with a pelvic mass
• Diagnosed with a pelvic mass
• Undergoing genetic testing through our commercial offering
• 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.

You may not qualify if:

• n/a

Sponsors & Collaborators

• Aspira Women's Health: lead

Study Sites (1)

Silvana Franco

Austin, Texas, 78738, United States

Location

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Todd Pappas, PhD

  Aspira Women's Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: May 4, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)