Tumor BuddingNCT05610592
Tumor Budding in Patients With Colorectal Cancer Under Different MMR Status
An observational study of Tumor Budding and Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study investigates the ability of tumor budding to identify prognosis in different MMR states and different levels of tumor lymphocyte infiltration. Tumor budding is usually defined as an isolated single cancer cell or a cluster of up to four cancer cells located at the front of an infiltrating tumor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor Budding, Rectal Cancer
- What is being tested?
- total mesorectal exicision
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 1 Nov 2022
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Rectal cancer patients underwent curative surgery
Who may be able to join
- Confirmed colorectal adenocarcinoma cancer pathologically
- Underwent primary surgery
- With records for tumor budding staining
- Willing and able to provide written informed consent for participation in this study
- Non-complicated primary tumor (complete obstruction, perforation, bleeding)
Who cannot join
- With distant metastases at the time of initial diagnosis
- Without a complete pathological date
- Hereditary colorectal cancer
- Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Prognostic Impact of Tumor Budding and Tumor-infiltrating Lymphocytes in Patients With Colorectal Cancer Under Different MMR Status: A Single-Center, Open-Label, Retrospective, Observational Cohort Study
This study investigates the ability of tumor budding to identify prognosis in different MMR states and different levels of tumor lymphocyte infiltration. Tumor budding is usually defined as an isolated single cancer cell or a cluster of up to four cancer cells located at the front of an infiltrating tumor.
Read the detailed description
As a component of the tumor microenvironment, tumor budding is associated with the epidermal mesenchymal transition of tumor cells and may predict disease progression and poor survival. The current assessment of tumor budding levels is mainly based on the ITBCC grading system. The dMMR phenotype of colorectal cancer is associated with the generation of non-self-recognizing neoantigens by the immune system, with tumor-associated extensive inflammatory cell infiltration, and often the dMMR phenotype of colorectal cancer has a lower level of outgrowth, possibly with the generation of local immune responses capable of eradicating tumor budding cells. The prognostic value of the conventional tumor budding grading system has been validated mainly in stage I and II colorectal cancers and does not consider the effect of MMR status on tumor budding. This retrospective study is designed to investigate whether the high grade of tumor budding under high immune response status implies immune escape of tumor cells and brings worse survival outcome, establish a more independent risk grading system to maximize the prognostic value of tumor budding in dMMR phenotype of colorectal cancer in combination with tumor-infiltrating lymphocytes.
- Conditions
- Tumor Budding, Rectal Cancer
- Being tested
- total mesorectal exicision
- Keywords
- Tumor budding, Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total mesorectal exicisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer | patients underwent curative surgery Receives: Procedure: total mesorectal exicision |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year event-free survival rate
Measured: 5 years after the surgery
Secondary outcomes (2)
5-year overall survival rate
Measured: 5 years after the surgery
Local recurrence
Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis
Measured: 5 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Jan 2009
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tumor BuddingStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610592
- Sponsor's protocol ID
- GIHSYSU-31
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous information may be provided upon reasonable request
Publications
Xie H, Zeng Z, Hou Y, Ye F, Cai T, Cai Y, Xiong L, Li W, Liu Z, Liang Z, Luo S, Zheng X, Huang L, Liu H, Kang L. Effects of tumour budding on adjuvant chemotherapy in colorectal cancer. BJS Open. 2024 Jan 3;8(1):zrad115. doi: 10.1093/bjsopen/zrad115.
PubMed 38190579
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Tumor Budding and Tumor-infiltrating Lymphocytes in Patients With Colorectal Cancer Under Different MMR Status: A Single-Center, Open-Label, Retrospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05610592
- Acronym / sponsor ID
- GIHSYSU-31
- Conditions
- Tumor Budding, Rectal Cancer
- Keywords
- Tumor budding, Rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 9 Nov 2022 (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.
This study investigates the ability of tumor budding to identify prognosis in different MMR states and different levels of tumor lymphocyte infiltration. Tumor budding is usually defined as an isolated single cancer cell or a cluster of up to four cancer cells located at the front of an infiltrating tumor.
Detailed description
As a component of the tumor microenvironment, tumor budding is associated with the epidermal mesenchymal transition of tumor cells and may predict disease progression and poor survival. The current assessment of tumor budding levels is mainly based on the ITBCC grading system. The dMMR phenotype of colorectal cancer is associated with the generation of non-self-recognizing neoantigens by the immune system, with tumor-associated extensive inflammatory cell infiltration, and often the dMMR phenotype of colorectal cancer has a lower level of outgrowth, possibly with the generation of local immune responses capable of eradicating tumor budding cells. The prognostic value of the conventional tumor budding grading system has been validated mainly in stage I and II colorectal cancers and does not consider the effect of MMR status on tumor budding. This retrospective study is designed to investigate whether the high grade of tumor budding under high immune response status implies immune escape of tumor cells and brings worse survival outcome, establish a more independent risk grading system to maximize the prognostic value of tumor budding in dMMR phenotype of colorectal cancer in combination with tumor-infiltrating lymphocytes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer | – | Procedure: total mesorectal exicisionpatients underwent curative surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients underwent curative surgery
Key inclusion criteria (5 listed)
- Confirmed colorectal adenocarcinoma cancer pathologically
- Underwent primary surgery
- With records for tumor budding staining
- Willing and able to provide written informed consent for participation in this study
- Non-complicated primary tumor (complete obstruction, perforation, bleeding)
Key exclusion criteria (4 listed)
- With distant metastases at the time of initial diagnosis
- Without a complete pathological date
- Hereditary colorectal cancer
- Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total mesorectal exicision | Procedure or surgery | Rectal cancer |
Primary outcome
5-year event-free survival rate
Time frame: 5 years after the surgery
2 secondary outcomes
5-year overall survival rate
Time frame: 5 years after the surgery
Local recurrence
Time frame: 5 years after the surgery
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 9 Nov 2022.
- Derived from this study: PubMed 38190579Xie H, Zeng Z, Hou Y, Ye F, Cai T, Cai Y, Xiong L, Li W, Liu Z, Liang Z, Luo S, Zheng X, Huang L, Liu H, Kang L. Effects of tumour budding on adjuvant chemotherapy in colorectal cancer. BJS Open. 2024 Jan 3;8(1):zrad115. doi: 10.1093/bjsopen/zrad115.
- Individual participant dataSharing planned: Undecided. Anonymous information may be provided upon reasonable request
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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 Tumor Budding and Rectal Cancer, run by Sun Yat-sen 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 5 inclusion and 4 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 9 Nov 2022. 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?
5-year event-free survival rate (time frame: 5 years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610592, which also lists 1 linked publication.
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 9 Nov 2022.