Clinical Trials

Inclusion Criteria – Cohort B (Benign control)

• Women ≥ 45 years of age and meet at least one of the following criteria:
  • Abnormal uterine bleeding;
  • Postmenopausal bleeding;
  • Asymptomatic, presenting for well-woman exam that will include a screening Pap test or vaginal speculum exam.

Exclusion Criteria – Cohort B (Benign control)

• Prior hysterectomy.
• Current known pregnancy diagnosis.
• Any prior pelvic or vaginal radiotherapy.
• Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years.
• Chemotherapy within the past 5 years\.
• Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia.
• Current biopsy-proven endometrial cancer or endometrial hyperplasia.
• Endometrial biopsy/sampling within the preceding 1 month.

Inclusion Criteria – Cohort C (Cancer / Hyperplasia)

• Women will be ≥ 18 years of age and meet at least one of the following criteria:
  • Presence of biopsy-proven Endometrial Cancer (any histology, including uterine carcinosarcoma) with surgical intervention planned. (Surgical intervention can include hysterectomy or D&C);
  • Presence of biopsy-proven AEH or EIN with surgical intervention planned. (Surgical intervention can include hysterectomy or D&C).

Exclusion Criteria – Cohort C (Cancer / Hyperplasia)

• Undergoing surgical procedure for recurrent or metastatic endometrial cancer.
• Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current endometrial cancer diagnosis.
• Prior hysterectomy.
• Current known pregnancy diagnosis.
• Prior or current biopsy-proven cervical cancer.
• Presence of concomitant biopsy-proven cervical dysplasia.
• Any prior pelvic or vaginal radiotherapy.
• Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years.
• Chemotherapy within the past 5 years.

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

Eligibility last updated 01/31/24. Questions regarding updates should be directed to the study team contact.