Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.