CClinicalTrials.gg
TerminatedNCT04668521OVA360Updated Dec 26, 2023

Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

An observational study in Adnexal Mass, Germline BRCA1 Gene Mutation and Germline BRCA2 Gene Mutation, sponsored by Aspira Women's Health. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Aspira Women's Health · Observational

Why this study was terminated
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
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
215
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Adnexal Mass
  • Germline BRCA1 Gene Mutation
  • Germline BRCA2 Gene Mutation
  • Hereditary Breast and Ovarian Cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 215 is close to the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Aspira Women's Health is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women with or without a pelvic mass.

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:

  • n/a
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
215 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherOVA360

    Multifactorial Risk Assessment for Breast \& Ovarian Cancer Risk Detection

06

What researchers measure

Primary outcomes

  1. OVA360

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

    Time frame: 12 months

07

Study locations

1 site
  • Silvana Franco
    Austin, Texas 78738, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04668521
Lead sponsor
Aspira Women's Health
Responsible party
Sponsor
First posted
Dec 16, 2020
Start date
May 4, 2020
Primary completion
Dec 15, 2023
Completion
Dec 15, 2023
Last update
Dec 26, 2023

Study contacts

Todd Pappas, PhD
principal investigator · Aspira Women's Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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