Translational Study of MSS, TP53 Mutation and Chromosome Instability Relationship in Endometrial Carcinoma

Not yet recruiting

• Conditions: TP53 Gene Mutation; Microsatellite Stable Endometrial Carcinoma; Endometrial Neoplasms; Chromosomal Instability

• Registration Number: NCT06521684
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The objective is to understand the relationship between TP53 mutation, MSS and chromosome instability in endometrial cancer and the effect on clinical prognosis.We will collect a small amount of tumor tissue samples. NGS panel detection and WGD/AS analysis were performed on the tissue. Paracancer tissue was used as a negative control and relevant information in medical records during the operation. Then we will collect clinical diagnosis and disease information through telephone follow-up after the completion of the operation.

Detailed Description

The test is sequenced using Illumina high-throughput sequencers and accompanying kits. Conduct preliminary quality control on the samples, and the tumor cell content of the tissue samples shall not be less than 30%. Tissue DNA was extracted from tumor tissue samples according to the instructions of the QIAGEN DNA extraction kit. Samples qualified for quality control shall be arranged for further library construction. The extracted DNA samples were sequentially purified by fragment purification, terminal repair, splicing, fragment size selection, PCR amplification, product purification, library enrichment, and library product quality control. After qualified quality control, the constructed library was sequenced by Illumina matching kit. Bioinformatics analysis would be conducted.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Study Start: 2024-09-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• willing to participate in the study and sign the informed consent
• age ≥18 years old
• researchers evaluated that it was suitable to participate in this translational study
• Endometrial cancer was confirmed histologically
• histopathological molecular classification was consistent with pMMR type and POLE wild type
• The tumor tissue obtained by operation was the primary lesion

Exclusion Criteria

• Received chemotherapy within 14 days prior to sample collection, or received anti-tumor drug therapy such as radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, within 21 days prior to sample collection
• previously treated with KIF18A inhibitors
• researchers believed that the subjects were not suitable for the translational study for other reasons

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TP53 mutation	2025-06-30	TP53 mutation
Chromosomal instability	2025-06-30	Chromosomal instability (Whole genome duplication, Aneuploidy)
microsatellite stability status	2025-06-30	microsatellite stability status

Secondary Outcome Measures

Name	Time	Method
recurrence	2026-06-30	disease recur