Rectal Cancer PatientsNCT07202169
Study of Intramural Spread Pattern in Low Rectal Cancer.
An observational study of Rectal Cancer Patients and Rectal Cancer Stage, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to study the law of intramural diffusion of low rectal cancer in different stages, and to explore the relationship between intramural diffusion of low rectal cancer and the distal resection margin during operation, so as to provide theoretical basis for clinicians to formulate accurate and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Patients, Rectal Cancer Stage
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ultra-low rectal cancer
Who may be able to join
- Patients aged 18-75 years old
- Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma
- Tumor lower margin ≤ 5 cm from the anal verge
- No distant metastasis such as lung, liver and other organs
Who cannot join
- Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.)
- Patients with malignant tumors in other parts of the body
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Whenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: Pattern of the Intramural Spread of Ultralow Rectal Cancer With the Resection Margin.
The purpose of this study is to study the law of intramural diffusion of low rectal cancer in different stages, and to explore the relationship between intramural diffusion of low rectal cancer and the distal resection margin during operation, so as to provide theoretical basis for clinicians to formulate accurate and individualized treatment plans, and help improve the prognosis and quality of life of patients.
- Conditions
- Rectal Cancer Patients, Rectal Cancer Stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with T1 ultra-low rectal cancer | Not described | |
| Patients with T2 ultra-low rectal cancer | Not described | |
| Patients with T3 ultra-low rectal cancer | Not described | |
| Patients with T4 ultra-low rectal cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the distance of intramural spread
Measured: 2023.01-2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Dec 2024
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202169
- Sponsor's protocol ID
- KY2025-R091
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of the Intramural Spread of Ultralow Rectal Cancer With the Resection Margin.
- ClinicalTrials.gov ID
- NCT07202169
- Acronym / sponsor ID
- KY2025-R091
- Conditions
- Rectal Cancer Patients, Rectal Cancer Stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 1 Oct 2025 (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 purpose of this study is to study the law of intramural diffusion of low rectal cancer in different stages, and to explore the relationship between intramural diffusion of low rectal cancer and the distal resection margin during operation, so as to provide theoretical basis for clinicians to formulate accurate and individualized treatment plans, and help improve the prognosis and quality of life of patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with T1 ultra-low rectal cancer | – | – |
| Patients with T2 ultra-low rectal cancer | – | – |
| Patients with T3 ultra-low rectal cancer | – | – |
| Patients with T4 ultra-low rectal cancer | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ultra-low rectal cancer
Key inclusion criteria (4 listed)
Key exclusion criteria (2 listed)
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
the distance of intramural spread
Time frame: 2023.01-2024.12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer Patients and Rectal Cancer Stage, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the distance of intramural spread (time frame: 2023.01-2024.12). 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 1 Oct 2025.