Ensayos clínicos

Inclusion Criteria: 

• Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.
• Willing and able to comply with scheduled visits, investigational plan, and other procedures.
• Females:
  • Aged > 45 for benign and pre-malignant cases;
  • All ages with positive biopsies.
• Presence of uterus.
• Scheduled for hysterectomy for reasons including but not limited to:
  • Suspected endometrial atypical hyperplasia (EAH);
  • Clinical suspicion of endometrial cancer and other suspected reproductive  cancers and sarcoma;
  • Confirmed endometrial carcinoma on biopsy;
  • Benign conditions including, but not limited to, vaginal prolapse, fibroids, ovarian cysts,women going to surgery for AUB, or irregular bleeding not responsive to conservative treatment.

Exclusion Criteria:

• Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.
• Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgment of the investigator.
• Women who have undergone a hysterectomy.
• Women with a known history of endometrial cancer.
• Women who have received prior treatment for endometrial cancer.
• Inability or unwillingness to sign informed consent.
• Contraindication to surgery.
• Women who have used a tampon within 7 days of surgery.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/5/2024. Questions regarding updates should be directed to the study team contact.