Is NCT05051722 recruiting in Miami, FL?

Yes, NCT05051722 is currently recruiting participants at its Miami, FL location. This endometrial cancer clinical trial is actively enrolling qualified participants.

How do I join the endometrial cancer clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Endometrial Cancer Clinical Trial in Miami, FL

About This Endometrial Cancer Study in Miami

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.

Sponsor: Mayo Clinic

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT05051722) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Endometrial Cancer Treatment Options in Miami, FL

If you're searching for endometrial cancer treatment options in Miami, FL, this clinical trial (NCT05051722) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced endometrial cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all endometrial cancer clinical trials near you to find additional studies recruiting in your area.

Endometrial Cancer Clinical Trial in Miami, FL

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Why Participate?

Simple Process

About This Endometrial Cancer Study in Miami

Who Can Participate

Inclusion Criteria

Exclusion Criteria

Frequently Asked Questions

Q:Is this study available in Miami?

Q:Is it safe to participate?

Q:Will I be compensated?

Q:Can I leave the trial if I change my mind?

Endometrial Cancer Treatment Options in Miami, FL

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