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NCT04668521 Clinical Trial

Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

Adnexal Mass Clinical Trial

— OVA360  

Official title:
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04668521
Other study ID # 05-2019
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 4, 2020
Est. completion date December 15, 2023

Study information
Verified date December 2023
Source Aspira Women's Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 215
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Silvana Franco Austin Texas

Sponsors (1)
Lead Sponsor Collaborator
Aspira Women's Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary OVA360 Identify the molecular key driver of Ovarian cancer and develop a diagnostic test for early Ovarian cancer detection 12 months
See also
  Status Clinical Trial Phase
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Completed NCT06366997 - Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test
Completed NCT00987649 - Ovarian Cancer Risk Estimation in Patients With Pelvic Mass N/A
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Recruiting NCT05842629 - Improved Diagnosis of Ovarian Cancer
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Terminated NCT04487405 - A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
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Not yet recruiting NCT03442881 - The Use of International Ovarian Tumor Analysis and Assessment of Adnexal Neoplasia in Differentiating Malignant and Benign Adnexal Masses N/A
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Active, not recruiting NCT04051502 - ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
Recruiting NCT05051722 - Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Completed NCT03593681 - Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy
Completed NCT02520115 - Folate Receptor in Diagnosing Ovarian Cancer Using Serum Samples From Patients With Newly Diagnosed Pelvic Mass or Previously Diagnosed Ovarian Cancer Phase 1
Recruiting NCT05461872 - Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES
Completed NCT03297112 - Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery Early Phase 1
Completed NCT03837327 - Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy