Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation

NCT06672341 | Not Yet Recruiting DMC

• 1 other identifier: 2410-Exp098
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study aims to assess high-risk patients using both liquid-based cytology and cervical methylation testing. The results will be compared with the traditional hysteroscopic pathological findings to determine the sensitivity and specificity of these methods for early detection of endometrial cancer, thereby evaluating their potential application in early screening. Primary Objectives：

1. 1.To evaluate the sensitivity, specificity, and accuracy of endometrial cytology for screening endometrial cancer.
2. 2.To assess the sensitivity, specificity, and accuracy of methylation testing for screening endometrial cancer.
3. 3.To perform further molecular testing on tissue samples obtained from endometrial cytology and cervical methylation tests, aiming to explore early screening-sensitive indicators.
4. 4.To determine the value of endometrial cytology in evaluating the efficacy of fertility-sparing treatments for endometrial cancer.
5. 5.To assess the value of methylation testing in evaluating the efficacy of fertility-sparing treatments for endometrial cancer.

Conditions

Endometrial Cancer; Methylation; Cytology; Fertility Preservation; Screening Tool; Liquid Biopsy; Non-invasive

Keywords

Endometrial Cancer; screening; methylation; Cytology; Liquid-Based Cytology Test; Early diagnosis; fertility-sparing; liquid biopsy; non-invasive

Outcome Measures

Primary Outcomes (1)

• comparing to the traditional hysteroscopic pathological findings to determine the sensitivity and specificity of Endometrial Cytology and Cervical Methylation Testing

  From enrollment to the end of treatment at 1 weeks

Interventions

Endometrial Cytology Testing DIAGNOSTIC_TEST

Endometrial Cytology Examination Liquid-based endometrial cytology is an emerging minimally invasive screening technique. This method involves collecting endometrial cells and tissues from the uterus and its downstream anatomical structures. The samples are preserved and analyzed using either liquid-based cytology techniques or tissue smear methods to reach a pathological diagnosis. Compared to invasive procedures such as fractional curettage, liquid-based cytology offers advantages in the screening of endometrial cancer, including being minimally invasive, convenient, and low-risk.

Cervical Methylation Testing DIAGNOSTIC_TEST

Cervical Cell Methylation Testing Cervical cell methylation testing is another promising method for methylation-based screening of endometrial cancer. This approach targets specific genes that undergo methylation in the early stages of endometrial cancer. The combined methylation analysis of four genes (CD01, BHLHE22, ACTB, and SEPTIN9) uses menstrual blood or vaginal secretions as samples, offering advantages such as safety, non-invasiveness, and self-collection. This method has shown high sensitivity and specificity for the early detection of endometrial cancer. Ongoing research suggests that the sensitivity and specificity of cervical cell methylation testing can reach 93.2% and 96%, respectively, although this data is yet to be published.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center.

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• Color Doppler ultrasound indicating intrauterine masses or abnormal endometrial thickening (for postmenopausal women not receiving hormone replacement therapy, endometrial thickness \>5mm).
• Patients undergoing follow-up and efficacy evaluation for fertility-sparing treatment of endometrial cancer or atypical endometrial hyperplasia.
• Patients with endometrial thickening following endocrine therapy for breast cancer.
• Signed informed consent form.
• Good compliance.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Diagnosed with cervical cancer.
• Severe systemic complications preventing hysteroscopy.
• Pregnant or recent history of miscarriage.
• Acute genital tract infection or pelvic inflammatory disease.
• Insertion of an intrauterine device.
• Sexual activity, vaginal douching, or medication use within 24 hours.

Sponsors & Collaborators

• Yulan Ren: lead

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Biospecimen

Retention: SAMPLES WITH DNA

Samples of Endometrial Tissue and Cell

MeSH Terms

Conditions

Endometrial Neoplasms; Disease

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

zhai

CONTACT

+86 13757760716; 24211230044@m.fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 4, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11