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

NCT06521684 | Not Yet Recruiting

• 1 other identifier: ECMTC
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Neoplasms; TP53 Gene Mutation; Chromosomal Instability; Microsatellite Stable Endometrial Carcinoma

Keywords

Endometrial Cancer; Chromosomal Instability; microsatellite stability; TP53 Gene Mutation; Whole genome duplication

Outcome Measures

Primary Outcomes (3)

• microsatellite stability status

  microsatellite stability status

  2025-06-30

• TP53 mutation

  TP53 mutation

  2025-06-30

• Chromosomal instability

  Chromosomal instability (Whole genome duplication, Aneuploidy)

  2025-06-30

Secondary Outcomes (1)

• recurrence

  2026-06-30

Eligibility Criteria

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

Study Population

Prospective and retrospective samples were collected from September 1, 2024 to June 30, 2025, with an estimated total sample size of 110 cases, including 80 fresh tumor tissues and 30 archival tumor tissues. There were 40 TP53 mutations (high copy type) and 70 TP53 negative (MSS type).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Preserved or fresh tumor tissue. Tumor tissue samples were embedded in paraffin wax, section thickness was 6μm, and section number was 10 (surgical tissue) or 15 (puncture tissue). Tumor cell content \> 30%.

MeSH Terms

Conditions

Endometrial Neoplasms; Chromosomal Instability

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; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genomic Instability

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07