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 pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.

 

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:

Inclusion Criteria for Cohort 1:

Women will be ≥45 years of age and meet at least one of the following criteria:

- Abnormal uterine bleeding

- Postmenopausal bleeding

Exclusion Criteria for Cohort 1:

- Prior hysterectomy

- Current known pregnancy diagnosis

- Any prior pelvic or vaginal radiotherapy

- Any prior cancer (except basal cell skin cancer) 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 - -

- Current biopsy-proven benign endometrial polyp

- Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium

Inclusion Criteria for Cohort 2:

Women will be ≥18 years of age and meet at least one of the following criteria:

- Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and
surgical intervention planned. Surgical intervention can include any of the following:
hysterectomy, D&C, hysteroscopic resection

- Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention
can include any of the following: hysterectomy, D&C, hysteroscopic resection, etc)

Exclusion Criteria for Cohort 2:

- Undergoing surgical procedure for recurrent or metastatic EC

- Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC
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 prior cancer (except basal cell skin cancer) within the past 5 years

- Chemotherapy within the past 5 years

- Prior intervention or surgery with intent to completely remove the target pathology

Inclusion Criteria for Cohort 3:

Women will be ≥18 years of age, have a cervix and meet at least one of the following
criteria:

- History of current abnormal cervical/endocervical Pap test for which the patient is
presenting for colposcopy

- Cervical mass identified on physical exam and patient referred for cervical biopsy,
even if colposcopy not recommended or indicated

- 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:

Exclusion Criteria for Cohort 3:

- History of pelvic or vaginal radiotherapy

- Prior total hysterectomy (cervix removed) for any indication

- Current known pregnancy diagnosis

- 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

- Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer
surveillance after prior curative intent treatment and no current Pap abnormality or
cervical mass

- Prior intervention or surgery with intent to completely remove the target pathology

Inclusion Criteria for Cohort 4:

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

- 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.

- Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of
fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be
confirmed.

Exclusion Criteria for Cohort 4:

- Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned
gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps,
or adenomyosis

- Any surgery within the past 3 months

- Prior hysterectomy

- Current known pregnancy diagnosis

- Prior or current biopsy-proven gynecologic cancer

- Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia

- Prior pelvic or vaginal radiotherapy

- Any prior cancer (except basal cell skin cancer) within the past 5 years

- Chemotherapy within the past 5 years

- 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 for 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;

Exclusion Criteria for Cohort 5:

- Pap test or cervical biopsy within the past 1 month

- Endometrial biopsy or office hysteroscopy within the past 1 month

- Any surgery within the past 3 months

- Prior hysterectomy

- Current known pregnancy diagnosis

- Prior or current biopsy-proven gynecologic cancer

- Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia

- Prior pelvic or vaginal radiotherapy

- Any prior cancer (except basal cell skin cancer) within the past 5 years

- Chemotherapy within the past 5 years

- Criteria met for inclusion in any of the other study cohorts

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

Eligibility last updated 11/15/22. Questions regarding updates should be directed to the study team contact.

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 C.C.R.C.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions