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

Inclusion Criteria

• COHORT 1: Patients will be ≥ 45 years of age, have a uterus and meet at least one of the following criteria: * Abnormal uterine bleeding * Postmenopausal bleeding OR Patients will be ≥ 18-44 years of age, have a uterus, and meet the following criteria * Abnormal uterine bleeding and one or more of the following EC risk factors: ** BMI ≥30 kg/m2, or ** Having a clinical diagnosis of polycystic ovarian syndrome (PCOS), or ** Any history of tamoxifen use
• COHORT 2: Patients will be ≥ 18 years of age, have a uterus, 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)
• COHORT 3: Patients 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 (any current ASCCP guideline criteria met for colposcopy) 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) ** Patients with prior supracervical hysterectomy are eligible for this cohort
• COHORT 4: Patients will be ≥ 45 years of age, have a uterus and 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 (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.
• COHORT 5: Patients will be ≥ 45 years of age, have a uterus, and meet the following criteria: * Presenting for a gynecology wellness 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
• COHORT 6: Patients ≥ 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 and cervix and at least 1 intact fallopian tube (without prior tubal ligation/occlusion) ** For vaginal fluid collection, patient must have a uterus, cervix, and at least 1 intact ovary and fallopian tube; for blood collection, patient may have had a remote benign hysterectomy, endometrial ablation, tubal ligation, tubal occlusion, or bilateral salpingectomy
• COHORT 7: Patients 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 * Presence of uterus, cervix and at least 1 fallopian tube (without prior tubal ligation/occlusion) (inclusion for vaginal fluid biospecimens) ** For vaginal fluid, patient must have a uterus, cervix, and at least 1 intact ovary and fallopian tube; for blood collection, patient may have had a remote benign hysterectomy, endometrial ablation, tubal ligation, tubal occlusion, bilateral salpingectomy, or oophorectomy

Exclusion Criteria

• COHORT 1: * Absence of a uterus (i.e 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 for cancer treatment within the past 5 years (exception is a history of tamoxifen use within the ≥ 18-44 age group at the time of study enrollment) * 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
• COHORT 2: * Undergoing surgical procedure for recurrent or metastatic EC * Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis * Absence of a uterus (i.e. 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 for cancer treatment within the past 5 years * Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode
• 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 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 * 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 to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode
• 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 * Absence of a uterus (i.e. 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 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 * Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis * Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode
• 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 * Absence of a uterus (i.e. 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 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 * Criteria met for inclusion in any of the other study cohorts
• 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
• 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