Methylated DNA Markers for Endometrial Cancer Detection
(ECHO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop a simple test to detect gynecological cancers, such as endometrial, ovarian, and cervical cancer, using DNA markers found in vaginal fluid and blood. By analyzing samples from patients with certain symptoms or conditions, it will help doctors diagnose these cancers early. The trial seeks women who have experienced specific gynecologic issues, such as abnormal bleeding or biopsy-proven cancer, or those undergoing surgery for suspected gynecologic cancer.
As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to earlier cancer detection and improved outcomes.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who have had chemotherapy within the past 5 years, which might suggest that certain treatments could affect eligibility.
What prior data suggests that this cancer detection method is safe?
Research has shown that collecting blood is generally safe when performed correctly. The World Health Organization (WHO) provides guidelines to ensure safety during blood draws, such as using gloves and special needles to prevent infections and accidents. These practices make blood collection a low-risk procedure for participants.
Studies have confirmed that tampons are safe to use. They have been researched for many years and are closely regulated. Tampons undergo strict safety checks to ensure compatibility with the body and to maintain the natural balance of bacteria in the vagina.
Overall, both blood and tampon collection are well-tolerated and considered safe based on available research. Participants in clinical trials involving these methods should feel reassured about the procedures.12345Why are researchers excited about this trial?
Researchers are excited about leveraging Methylated DNA Markers (MDMs) in cancer detection because this method offers a non-invasive approach to identifying endometrial, ovarian, and cervical cancers. Unlike traditional diagnostic methods, which often rely on biopsies or imaging, MDMs can be detected through simple blood or tampon collections. This approach not only reduces discomfort but also allows for earlier and potentially more accurate detection of these cancers. By focusing on the unique DNA methylation patterns associated with cancer, this technique has the potential to improve early diagnosis, leading to better patient outcomes.
What evidence suggests that this trial's methods could be effective for detecting endometrial cancer?
This trial will evaluate the effectiveness of methylated DNA markers for detecting endometrial cancer. Research has shown that certain DNA markers can effectively detect this cancer. In one study, these markers correctly identified cancer in about 86 out of 100 cases and correctly ruled it out in about 88 out of 100 cases. Another study found these markers reliable and easy to use, as they don't require invasive procedures. This evidence suggests that these markers could help detect endometrial cancer early, which is crucial for successful treatment.678910
Who Is on the Research Team?
Jamie N Bakkum-Gamez, M.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I MDM-based cancer detection
Exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies
Phase II MDM-based cancer detection
Develop predictive models from a panel of EC-specific and OC-specific MDMs and validate their performance in identifying underlying cancers within vaginal fluid and plasma
Follow-up
Participants are monitored for safety and effectiveness after the biomarker development study
What Are the Treatments Tested in This Trial?
Interventions
- Blood Collection
- Tampon Collection
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Endometrial Cancer Detection by DNA Methylation ...
Conclusion: These findings demonstrate that DNA methylation analysis in cervical Pap brush samples may be helpful for EC detection, broadening ...
DNA methylation detection is a significant biomarker for ...
The data showed that the sensitivity of dual gene methylation screening for endometrial cancer was 85.7%, and the specificity was 87.6%.
The accuracy of DNA methylation detection in endometrial ...
Cytology-based DNA methylation markers are feasible and accurate non-invasive methods for the early detection of endometrial cancer screening in high-risk ...
Unveiling DNA methylation: early diagnosis, risk ...
These results suggested that DNA methylation analysis might help predict EC patients which were less risky and suitable for fertility preservation therapy.
Research Progress of DNA Methylation Markers for ...
Reportedly, increased methylation of HAND2 is a hallmark of endometrial precancer, typically correlated with decreased RNA and protein levels.
Phlebotomy - StatPearls - NCBI Bookshelf
The basic tools required for a successful and safe blood draw include a tourniquet, an appropriate needle, gloves, alcohol wipes, and the ...
WHO guidelines on drawing blood: best practices in ...
The new WHO guidelines provide recommended steps for safe phlebotomy and reiterate accepted principles for drawing, collecting blood and transporting blood.
SOL-CARETM Safety Blood Collection Needle
This Safety Data Sheet for the products: SOL-CARE™ Safety Blood Collection Needle. SOL-CARE™ Safety Blood Collection Needle with Pre-attached Holder has been ...
Standards and Practice Guidelines for Venous Blood ...
Wear gloves to protect the patient and phlebotomist and to prevent infection [7]. For routine venous blood collection, non-sterile gloves are ...
WHO guidelines on drawing blood:
This can be achieved by improving sharps disposal, and by using safety needles with needle covers or retractable needles to minimize the risk of exposure to ...
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