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A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants

Megadott ok: 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

Key facts

Where
Austin, Chandler, Cincinnati, Columbus, Eden Prairie, Lake Worth, Lancaster és New Hyde Park, Egyesült ÁllamokSee the 9 sites

Where in Egyesült Államok

  • Hill Country OBGYN AssociatesAustin, Egyesült ÁllamokNo longer taking part
  • Women's Health ArizonaChandler, Egyesült ÁllamokNo longer taking part
  • Seven Hills Clinical Research GroupCincinnati, Egyesült ÁllamokNo longer taking part
  • MidTown OBGYNColumbus, Egyesült ÁllamokNo longer taking part
  • Premier OBGYN of MinnesotaEden Prairie, Egyesült ÁllamokNo longer taking part
  • Altus ResearchLake Worth, Egyesült ÁllamokNo longer taking part
  • May Grant OB/GYNLancaster, Egyesült ÁllamokNo longer taking part
  • Northwell HealthNew Hyde Park, Egyesült ÁllamokNo longer taking part
  • Square Care HealthNew Hyde Park, Egyesült ÁllamokNo longer taking part

Trial details

Who runs it
Aspira Women's Health
Trial code
NCT04487405
Record updated
2023. december 26.
Original description
The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.Read full original descriptionShow less

The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.

Inclusion: Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants; Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.

Exclusion: Patient is less than 18 years of age; Patient is not being treated in the U.S.

ClinicalTrials.gov NCT04487405