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

Launched by MAYO CLINIC · Sep 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new type of test that aims to detect certain gynecologic cancers—specifically endometrial, ovarian, and cervical cancers—using special markers found in vaginal fluid and blood. These markers are pieces of DNA that can indicate the presence of cancer. The goal is to develop a reliable test that can help identify these cancers earlier, which is important for better treatment outcomes.

Women aged 18 and older who have specific symptoms or conditions related to these cancers may be eligible to participate. For example, those with unusual bleeding or who are scheduled for surgery related to these cancers could qualify. Participants will provide samples of vaginal fluid and blood for testing, and the study will compare the results with existing medical conditions. It’s important to know that certain medical histories, like previous cancers or surgeries, may exclude someone from joining the trial. Overall, this research could lead to improved ways to detect cancers that affect women, potentially saving lives through earlier diagnosis and treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria for Cohort 1:
• Patients will be ≥45 years of age and meet one of the following criteria:
• • Abnormal uterine bleeding
• • Postmenopausal bleeding
• • OR
• • Patients ages 18 - 44 years of age and meet these criteria
• • Abnormal uterine bleeding
• • One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)
• 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:
• Patients 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
• • Received 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:
• 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 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 for the current lesion / diagnosis during the current episode
• Inclusion Criteria for Cohort 4:
• Patients 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 for the current lesion / diagnosis during the current episode
• Inclusion Criteria for Cohort 5:
• Patients with a uterus will be ≥45 years of age and should meet the following criteria:
• • Presenting for GYN wellness 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:
• Patients ≥50 years of age and:
• • Postmenopausal
• • 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 vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)
• Exclusion criteria for 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 for 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 vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)
• Exclusion criteria for 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
• • Current known pregnancy diagnosis