An observational study in Endometrial Cancer, Cervical Cancer and Atypical Endometrial Hyperplasia, sponsored by Mayo Clinic. Recruiting at 25 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Mayo Clinic · Observational
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Among 19 studies in Endometrial Neoplasms by Mayo Clinic — 12 open to participants now, 14 under way, none of them phase 3. Endometrial Neoplasms · Mayo Clinic.
Among the 19 studies in Endometrial Neoplasms by Mayo Clinic, this one is one of 2 that started in 2021, is one of 9 observational ones, reaches primary completion later than 6 of the 13 other live ones, and was the 8th registered.
1,426 studies on the registry are indexed under Endometrial Neoplasms; 471 are open to participants now.
Browse Endometrial Neoplasms studies →12 of the 19 studies in Endometrial Neoplasms by Mayo Clinic are open now, in 10 countries. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 21+ · Women only
Mayo Clinic · Sites in United States
Ages 45+ · Women only · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+ · Women only
Mayo Clinic · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 357 Endometrial Neoplasms studies recruiting now, 267 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 3 · Phase 4 1
First in 2016; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 3,110 is above the median of 179 across 331 observational studies indexed under Endometrial Neoplasms.
Median enrollment 30 across the 10 interventional studies, 191 across the 9 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
6 of the studies in Endometrial Neoplasms by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05407025Mayo ClinicTargeting Inflammation for Endometrial Cancer Prevention | 2026-12-31 |
| NCT06349642Mayo ClinicImmune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform | 2027-05 |
| NCT07285044Mayo ClinicThe Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas | 2027-05-15 |
| NCT07527143Mayo ClinicAcceptability of Testing DNA Markers in Vaginal Fluid for the Detection of Endometrial Cancer | 2027-06-10 |
| NCT06365905Mayo ClinicNon-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 19 studies in Endometrial Neoplasms by Mayo Clinic, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The overarching objective of this project is 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.
This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.
Detection of endometrial, ovarian, and cervical cancers at an early stage vastly increases the chances of cure and may also avert morbidity secondary to surgical staging, radiation, and/or chemotherapy. Despite the great successes of cervical cancer screening, comparable early detection methods for other gynecologic cancers and their precursors are not available. While nearly 1.5 million women per year in the United States are evaluated for abnormal uterine bleeding (AUB) or postmenopausal bleeding (PMB), the most common symptom of endometrial cancer, most undergo an invasive diagnostic biopsy with the finding of benign etiology.
Vaginal bleeding is often the only presenting symptom of women ultimately diagnosed with endometrial cancer (EC) or its precursor lesion, endometrial hyperplasia(EH). More than 90% of women with EC present with vaginal bleeding. Cervical cancer and cervical dysplasia can present as intermenstrual bleeding, post-coital bleeding, or other abnormal vaginal bleeding. However, most women who present with AUB or PMB have a benign etiology.
There are approximately 70 million women ≥45 years of age in the United States based on the most recent census data. Between 4-11% of women will be worked up for perimenopausal AUB or PMB in their lifetime. As only 5-10% of those women will have an EC or EH, there is a great clinical need for a less invasive clinical diagnostic test that can reliably distinguish between benign uterine bleeding and bleeding associated with an underlying endometrial cancer, cervical cancer, or a precursor lesion.
Patients presenting to a GYN or GYN Surgery Clinic for evaluation of symptoms or for consultation and planned procedures as outlined in the seven study cohort descriptions.
Inclusion Criteria for Cohort 1:
Patients will be ≥45 years of age and meet one of the following criteria:
OR
Patients ages 18 - 44 years of age and meet these criteria
Exclusion Criteria for Cohort 1:
Inclusion Criteria for Cohort 2:
Patients will be ≥18 years of age and meet at least one of the following criteria:
Exclusion Criteria for Cohort 2:
Inclusion Criteria for Cohort 3:
Patients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:
Exclusion Criteria for Cohort 3:
Inclusion Criteria for Cohort 4:
Patients will be ≥45 years of age and should meet at least one of the following criteria:
Exclusion Criteria for Cohort 4:
Inclusion Criteria for Cohort 5:
Patients with a uterus will be ≥45 years of age and should meet the following criteria:
Exclusion Criteria for Cohort 5:
Inclusion Criteria for Cohort 6:
Patients ≥50 years of age and:
Exclusion criteria for Cohort 6:
Inclusion criteria for Cohort 7:
Women will be ≥18 years of age and meet the following criteria:
Exclusion criteria for Cohort 7:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients ≥45 years of age, presenting with abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB). Patients ages 18 - 44 years of age, presenting with abnormal uterine bleeding (AUB) and a risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use). These presenting symptoms clinically warrant evaluation such as an endometrial biopsy to assess for underlying endometrial cancer, endometrial hyperplasia or other endometrial pathology.
Diagnostic Test: Vaginal Fluid Collection · Diagnostic Test: Blood Collection
Patients ≥18 years of age with biopsy-proven endometrial cancer (EC), atypical endometrial hyperplasia (AEH), or endometrial intraepithelial neoplasia (EIN) presenting for surgical management of their endometrial pathology.
Diagnostic Test: Vaginal Fluid Collection · Diagnostic Test: Blood Collection
Patients ≥18 years of age presenting for a clinically indicated colposcopy, cervical biopsy, or surgical excision, as follow-up for an abnormal Pap test or cervical mass identified on physical exam. Final clinical diagnoses within this cohort may include mild cervical intraepithelial neoplasia (CIN 1), moderate and/or severe CIN (CIN 2/3), adenocarcinoma in situ (AIS), invasive cervical cancers (adenocarcinoma or squamous cell carcinoma), or possibly benign findings.
Diagnostic Test: Vaginal Fluid Collection · Diagnostic Test: Blood Collection
Patients with any of four benign gynecologic conditions including: uterine fibroids, benign endometrial polyps, adenomyosis and endometriosis. All patients enrolled in this cohort will be undergoing clinically indicated gynecologic surgery (hysterectomy, myomectomy, polypectomy, or laparoscopic tissue excision) for the specific benign gynecologic condition. Verification of the final benign diagnosis will be based on pathology diagnosis of clinically-indicated tissue removed during surgery.
Diagnostic Test: Vaginal Fluid Collection · Diagnostic Test: Blood Collection
Healthy patients with a uterus, ≥45 years of age presenting for GYN wellness exam to serve as a control group. These patients will have no clinically evident gynecologic precancers, gynecologic cancers, or clinically evident or symptomatic benign gynecologic conditions. These patients will not have known or clinically suspected AUB, PMB, fibroids, endometriosis, benign endometrial polyps, or adenomyosis, nor will they have any active gynecologic or non-gynecologic acute medical conditions.
Diagnostic Test: Vaginal Fluid Collection · Diagnostic Test: Blood Collection
Patients ≥50 years of age and postmenopausal (12 months since LMP or available blood hormone levels confirming postmenopausal status) and an isolated adnexal mass or isolated bilateral adnexal masses being surgically removed. These patients may have a final diagnosis of any of the following: benign ovarian neoplasm, borderline tumor of the ovary, or clinically early-stage OC.
Diagnostic Test: Vaginal Fluid Collection · Diagnostic Test: Blood Collection
Patients ≥18 years of age with ovarian cancer (OC) (clinically probable based on distribution of pelvic/abdominal masses on imaging, elevated CA-125, ascites, and/or imaging-guided biopsy proven) presenting for neoadjuvant chemotherapy or primary surgical management (debulking or staging) of their OC. The umbrella of OC also includes fallopian tube cancer and primary peritoneal cancer. All histologies are eligible for enrollment.
Diagnostic Test: Vaginal Fluid Collection · Diagnostic Test: Blood Collection
A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.
Also known as: Vaginal Fluid
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.
Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based endometrial cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of endometrial cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
Time frame: 18 months
Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort.
Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based ovarian cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of ovarian cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
Time frame: 18 months
Using 95% specificity cutoffs of the final MDM EC panel, determine the false positive rate among women undergoing surgical removal of common benign gynecologic pathology
As part of this biomarker test development, understanding whether common non-cancerous uterine or gynecologic conditions may also lead to the finding of currently apparent endometrial cancer-specific MDMs in vaginal fluid is critical in determining specificity, positive predictive value, and negative predictive value of the test.
Time frame: 18 months
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Started Aug 2021 (actual). Primary completion is estimated for Jul 2027, 71 months after the start.
Of 130 non-industry observational studies under Endometrial Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 206. This study's planned 71 months is close to that.
Counting every sponsor, half of 150 studies reached it within 105 months; a quarter within 32 and three quarters within 206.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: primary completion Dec 2026 → Jul 2027 and completion Jun 2027 → Sep 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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