CLINICAL TRIAL / NCT05051722

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