Study and Transformation of Tumor Molecular Features Screening Model of Endometrial Carcinoma Surgical Approach

NCT05894915 | Unknown

• 1 other identifier: 2022PHB105-002
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

Brief Summary

At present, endometrial carcinoma is one of the three most common malignant tumors in gynecology, and the incidence has been increasing year by year, causing a large health and economic burden to the society. Therefore, researchers regard the hierarchical management and precise diagnosis and treatment of endometrial carcinoma as an important direction for future research. In 2013, the American Cancer Genome Atlas Research Network proposed a molecular typing of endometrial carcinoma. In recent years, international scholars have conducted relevant research on the molecular characteristics of a large number of endometrial carcinomas and immunity, targeted therapy and postoperative adjuvant chemoradiotherapy. However, the molecular characteristics of endometrial carcinoma and the choice of surgical route are still in a relatively lacking state. The previous research of the investigators' group was the first to propose the concept of selecting surgical routes for endometrial carcinoma based on molecular characteristics. Then, on this basis, the investigators' research group plans to carry out a prospective randomized controlled study to further analyze the impact of surgical routes on the short-term safety and long-term prognosis of endometrial carcinoma patients with different molecular characteristics, and transform it into a clinical decision-making technical index system for endometrial carcinoma surgical selection based on molecular characteristics and further promote and apply. The results of this study will make up for the shortcomings in the relevant fields of endometrial carcinoma research in the world to some extent, and become an important aspect of the decision-making system of clinical comprehensive precision diagnosis and treatment of endometrial carcinoma patients.

Conditions

Endometrial Carcinoma; Tumor Molecular Features Screening Model

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence rate of each group

  the proportion of radiographic or pathologically confirmed recurrence cases to the total number of cases in this group up to 2-year follow-up.

  2 year

Secondary Outcomes (8)

• time of the surgery process

  1 day

• intraoperative blood loss

  1 day

• Complication rate within 8 weeks after surgery

  8weeks

• average length of hospital stay

  1 month

• Tumor recurrence time

  2 year

Study Arms (2)

open surgery group

EXPERIMENTAL

Patients who met the inclusion criteria and excluded the exclusion criteria, and did not have high mutational burden characteristics after molecular testing, were randomly divided into open surgery group or laparoscopic surgery group according to 1:1.

Procedure: open surgery

laparoscopic surgery group

EXPERIMENTAL

Patients who met the inclusion criteria and excluded the exclusion criteria, and did not have high mutational burden characteristics after molecular testing, were randomly divided into open surgery group or laparoscopic surgery group according to 1:1.

Procedure: laparoscopic surgery

Interventions

open surgery PROCEDURE

Open surgery is a traditional surgery method.

open surgery group

laparoscopic surgery PROCEDURE

Laparoscopic surgery is a newly developed minimally invasive method.

laparoscopic surgery group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 40-80 years.
• Preoperative hysteroscopic biopsy pathology is endometrial carcinoma, preoperative imaging evaluation of tumor limited to uterine or extrauterine metastasis limited to pelvic or para-aortic lymph nodes.
• No liver and kidney function abnormalities and bone marrow suppression before surgery.
• ECOG score 0 points.
• Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
• Molecular testing has confirmed that the participant does not have high mutational burden characteristics (including POLE mutations, MSI-H, homologous recombinant repair pathway mutations).

You may not qualify if:

• Preoperative adjuvant therapy.
• Have contraindications to chemoradiotherapy and cannot receive postoperative adjuvant chemoradiotherapy.
• Previous history of other malignant tumors or other malignant tumors at the same time.
• Laparoscopic surgery transferred to open surgery for special reasons.
• unable or unwilling to comply with the requirements of the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Conversion to Open Surgery; Laparoscopy

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

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Wang zhiqi

CONTACT

8615611808362; wangzqnet@sina.com

Wang Junzhu

CONTACT

8618813123953; loiswang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Associate Professor

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share