Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer

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 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

Inclusion Criteria for Cohort 6:

Women ≥50 years of age and:

Postmenopausal status
At least 1 intact ovary
Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)
Planned surgery for the adnexal mass
For tampon collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)

Exclusion criteria - Isolated Adnexal Mass cohort: (Cohort 6)

Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)
Chemotherapy for cancer treatment within the past 5 years prior to collection
Clinically-suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection
Surgical candidates for recurrent ovarian cancer
History of pelvic or vaginal radiation therapy
Known current synchronous endometrial cancer or hyperplasia
Known current cervical, vaginal, or vulvar dysplasia

Inclusion criteria - OC Cohort: (Cohort 7)

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

Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology
Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy
At least one intact ovary
For tampon collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)

Exclusion criteria - OC Cohort (Cohort 7):

Patients with recurrent OC
Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years
Chemotherapy for cancer treatment within the past 5 years prior to collection
History of pelvic or vaginal radiation therapy
Known current synchronous endometrial cancer or hyperplasia
Known current cervical, vaginal, or vulvar dysplasia