Endometrial NeoplasmsNCT06521684
Translational Study of MSS, TP53 Mutation and Chromosome Instability Relationship in Endometrial Carcinoma
An observational study of Endometrial Neoplasms and TP53 Gene Mutation, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms, TP53 Gene Mutation, Chromosomal Instability
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Endometrial Neoplasms, Chromosomal Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
microsatellite stability status
microsatellite stability status
Measured: 2025-06-30
TP53 mutation
TP53 mutation
Measured: 2025-06-30
Chromosomal instability
Chromosomal instability (Whole genome duplication, Aneuploidy)
Measured: 2025-06-30
Secondary outcomes (1)
recurrence
disease recur
Measured: 2026-06-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521684
- Sponsor's protocol ID
- ECMTC
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Study of MSS, TP53 Mutation and Chromosome Instability Relationship in Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT06521684
- Acronym / sponsor ID
- ECMTC
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
microsatellite stability status
Time frame: 2025-06-30
microsatellite stability status
TP53 mutation
Time frame: 2025-06-30
TP53 mutation
Chromosomal instability
Time frame: 2025-06-30
Chromosomal instability (Whole genome duplication, Aneuploidy)
1 secondary outcome
recurrence
Time frame: 2026-06-30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms and TP53 Gene Mutation, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microsatellite stability status (time frame: 2025-06-30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.