A Study to Evaluate the Venn Ovarian CAncer Liquid Biopsy

Overview

About this study

The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Women age 18 years or older.
  • Able to provide a written informed consent and who understand and agree to all study procedures required.
  • A newly diagnosed adnexal mass was confirmed by imaging (computed tomography, ultrasonography, or magnetic resonance imaging) prior to enrollment.
  • Planned diagnostic procedure or surgery by the subject’s physician to remove adnexal masses within 90 days of imaging. (Note that diagnostic procedure typically includes biopsy (needle core or laparoscopic-directed), ascites cytology, pleural effusion cytology or FNA).
  • or
  • Women with newly diagnosed clinically benign adnexal mass(es) for whom surgery is not planned as determined by the treating physician.

Exclusion Criteria:

  • Had/Has a diagnosis of invasive malignancy (exception: non-melanoma skin cancers) in the previous 5 years.
  • Currently receiving or ever received any of the following prior cancer therapies in the previous 5 years: curative surgical resection, local or systemic chemotherapy, targeted therapy, immunotherapy including cancer vaccines, hormone therapy, or radiation therapy.
  • Pregnancy (by self-report of pregnancy status).
  • Current febrile illness.
  • Acute exacerbation or flare of an inflammatory condition requiring escalation in therapy.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
  • Poor health status or unfit to tolerate blood draw.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Tri Dinh, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20472107

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