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Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

NCT ID: NCT04668521

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-04

Study Completion Date

2023-12-15

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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COHORT A

Women with a pelvic mass, symptomatic or asymptomatic.

OVA360

Intervention Type OTHER

Multifactorial Risk Assessment for Breast \& Ovarian Cancer Risk Detection

COHORT B

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

OVA360

Intervention Type OTHER

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.

OVA360

Intervention Type OTHER

Multifactorial Risk Assessment for Breast \& Ovarian Cancer Risk Detection

Interventions

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OVA360

Multifactorial Risk Assessment for Breast \& Ovarian Cancer Risk Detection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female subject
* 18 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.

Exclusion Criteria

* n/a
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aspira Women's Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Pappas, PhD

Role: PRINCIPAL_INVESTIGATOR

Aspira Women's Health

Locations

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Silvana Franco

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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05-2019

Identifier Type: -

Identifier Source: org_study_id