IRB Study Number 24-035
Status Recruiting
Institute Taussig Cancer Institute
Description
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.
Inclusion Criteria
AUB/PMB cohort: (Cohort 1)
Women will be ≥45 years of age and meet at least one of the following criteria:
• Abnormal uterine bleeding
EC cohort: (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)
Cervix cohort: (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 (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)
Benign Uterine Pathology cohort: (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 (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.
Healthy Control cohort: (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; This includes conditions diagnosed within the past 6 months that have resolved
Isolated Adnexal Mass cohort: (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 and cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)
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
• Presence of uterus, cervix and at least 1 fallopian tube (without prior tubal ligation/occlusion) (inclusion for tampon biospecimen)
Exclusion Criteria
AUB/PMB cohort: (Cohort 1)
• 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 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
EC cohort: (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 current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years
• Chemotherapy 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
Cervix cohort: (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 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
Benign Uterine Pathology cohort: (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
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
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
