Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer and Cervical Cancer: a Phase II Clinical Study

Overview

About this study

The purpose of this study is to develop a uterine (endometrial and cervical) cancer detection test using unique endometrial cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid.

 

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 – AUB/PMB Cohort 1:

  • Women will be ≥ 45 years of age.
  • Abnormal Uterine Bleeding.or Postmenopausal bleeding.

 Exclusion Criteria – AUB/PMB Cohort 1:

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

Inclusion Criteria – EC Cohort 2:

  • Women will be ≥ 18 years of age.
  • Biopsy-proven EC (any histology, including uterine carcinosarcoma) OR biopsy showing AEH or EIN, with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D&C, hysteroscopic resection.

Exclusion Criteria – EC Cohort 2:

  • Undergoing surgical procedure for recurrent or metastatic EC.
  • Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis.
  • Prior hysterectomy.
  • Current known pregnancy
  • Prior or current biopsy-proven cervical cancer.
  • Presence of concomitant biopsy-proven cervical dysplasia.
  • Any prior cancer (except basal cell skin cancer) within the past 5 years.
  • Chemotherapy within the past 5 years.
  • Any prior pelvic or vaginal radiotherapy
  • Prior intervention or surgery with intent to completely remove the target pathology

Inclusion Criteria – Cervix Cohort 3:

  • Women will be ≥ 18 years of age.
  • Must have a cervix.
  • History of current abnormal cervical/endocervical Pap test (any current ASCCP guideline criteria met for colposcopy) for which the patient is presenting for colposcopy, OR cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated, OR planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible).

Exclusion Criteria – Cervix Cohort 3:

  • Prior total hysterectomy (cervix removed) for any indication.
  • Current known pregnancy
  • Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin.
  • Any prior cancer (except basal cell skin cancer) within the past 5 years.
  • Chemotherapy within the past 5 years.
  • Any prior pelvic or vaginal radiotherapy.
  • Women without a current Pap abnormality or cervical mass presenting for colposcopy surveillance following prior treatment for a lower genitak tract dysplasia or for surveillance after prior cancer treatment. 
  • Prior intervention or surgery with intent to completely remove the target pathology

Inclusion Criteria – Benign Uterine Pathology Cohort 4:

  • Women will be ≥ 45 years of age.
  • Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and/or clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps, OR undergoing any gynecologic surgery (i.e. myomectomy, polypectomy, laparoscopic resection of endometriosis) in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp(s) is anticipated to be confirmed.

Exclusion Criteria – Benign Uterine Pathology Cohort 4:

  • Prior hysterectomy
  • Current known pregnancy
  • Any surgery within the past 3 months.
  • Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis.
  • Prior or current biopsy-proven gynecologic cancer.
  • Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia.
  • Any prior cancer (except basal cell skin cancer) within the past 5 years.
  • Chemotherapy within the past 5 years.
  • Prior pelvic or vaginal radiotherapy.
  • Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis.
  • Prior intervention or surgery with intent to completely remove the target pathology

Inclusion Criteria – Healthy Control Cohort 5:

Women will be ≥ 45 years of age and should meet the following criteria:

  • Presenting for well-woman exam, ± Pap test.
  • No change in medical conditions, new diagnoses, or new medications within the past 6 months; This includes conditions diagnosed within the past 6 months that have resolved.

Exclusion Criteria – Healthy Control Cohort 5:

  • Prior hysterectomy.
  • Current known pregnancy
  • Any surgery within the past 3 months.
  • Pap test or cervical biopsy within the past 1 month.
  • Endometrial biopsy or office hysteroscopy within the past 1 month.
  • Prior or current biopsy-proven gynecologic cancer.
  • Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia.
  • Any prior cancer (except basal cell skin cancer) within the past 5 years.
  • Chemotherapy within the past 5 years.
  • Prior pelvic or vaginal radiotherapy.
  • Meets eligibility criteria for participation in any of the other 4 cohorts.

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

Rochester, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Open for enrollment

Contact information:

Maureen Lemens R.N.

(507) 293-1487

Lemens.Maureen@mayo.edu

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-20521077

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