Multifactorial Risk Assessment for Breast & Ovarian Cance... | NCT04668521

Studies
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

NCT04668521

Sponsor

Aspira Women's Health

Status

Terminated

Last Update Posted

Dec 26, 2023Actual

Enrollment

215Actual

Phase

Not provided

Conditions

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

Interventions

OVA360

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

cohort C looked at feasibility of genetics & protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences

Expanded Access Info

Start Date

May 4, 2020Actual

Primary Completion Date

Dec 15, 2023Actual

Completion Date

Dec 15, 2023Actual

First Submitted Date

Dec 9, 2020

First Submission Date that Met QC Criteria

Dec 9, 2020

First Posted Date

Dec 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2023

Last Update Posted Date

Dec 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

215Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
OVA360	Other	Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection	COHORT A COHORT B COHORT C

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women with or without a pelvic mass.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Todd Pappas, PhD	Aspira Women's Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Silvana Franco		Austin	Texas	78738	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D061325	Hereditary Breast and Ovarian Cancer Syndrome

Ancestor Terms

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010051	Ovarian Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided