Colon CancerNCT06655285
The Impact of Inflammatory Adhesion on the Prognosis of Colon Cancer Patients
An observational study of Colon Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- This was a retrospective study and no patient intervention was performed.
- How many people
- 229 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 27 Oct 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study utilized the Chinese multi-center database as well as the SEER 17 registries database. The Chinese multi-center database contains data of patients between January 2010 and December 2021, at 3 institutions. SEER*Stat software (version 8.4.1.1) was used for collecting 17 registries cohort data on patients diagnosed with NMIBC between 2010 and 2019.
Who may be able to join
- The patient was pathologically diagnosed as colon adenocarcinoma by endoscopic biopsy before operation.
- All patients were considered to have tumors invading adjacent organs during surgery
- All patients underwent radical surgery.
Who cannot join
- 1. Patients with distant metastasis, recurrent colon cancer and pT4b CRC were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: The Impact of Tumor-associated Inflammatory Adhesion on the Prognosis of Colon Cancer Patients: a Study Based on the SEER and Chinese Multi-center Databases
The purpose of this study is to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients.
Read the detailed description
In some colon cancer patients, although adhesions between the tumor tissue and surrounding organs are found during surgery, postoperative pathology confirms that the tumor has not directly invaded the adhered organs; instead, the adhesions are caused by tumor-associated inflammation. This condition is defined as tumor-associated inflammatory adhesion.
Currently, the impact of tumor-associated inflammatory adhesion on patient prognosis is still unclear. This study aims to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients through the Surveillance, Epidemiology, and End Results (SEER) and Chinese multi-center databases.
- Conditions
- Colon Cancer
- Being tested
- This was a retrospective study and no patient intervention was performed.
- Keywords
- Colon Cancer, Prognosis, Tumor-associated inflammatory adhesion
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This was a retrospective study and no patient intervention was performed.Other
This was a retrospective study and no patient intervention was performed.
| Study group | Role | What they receive |
|---|---|---|
| the U.S. National Cancer Center SEER database | SEER*Stat software (version 8.4.3) collected 17 registries cohort data on colon cancer patients between 2010 and 2019. Receives: Other: This was a retrospective study and no patient intervention was performed. | |
| Chinese multi-center database | Chinese multi-center database includes patients from January 2010 to December 2021 at 3 institutions. Receives: Other: This was a retrospective study and no patient intervention was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time (OS)
OS, defined as the time from the first diagnosis to death from any cause or the last follow-up for surviving patients
Measured: up to 10 years
Cancer-specific survival time (CSS)
CSS refers to the duration from diagnosis of a tumor until the patient succumbs to the tumor, excluding deaths from other causes.
Measured: up to 10 years
Recurrence free survival time (RFS)
RFS is the time from the time a patient achieved R0 resection after surgery to the time of recurrence or the end of follow-up.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start24 Oct 2024
- Primary completion26 Oct 2024
- Study completion27 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655285
- Sponsor's protocol ID
- NCC3650
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2024
- Last updated
- 7 Nov 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Tumor-associated Inflammatory Adhesion on the Prognosis of Colon Cancer Patients: a Study Based on the SEER and Chinese Multi-center Databases
- ClinicalTrials.gov ID
- NCT06655285
- Acronym / sponsor ID
- NCC3650
- Conditions
- Colon Cancer
- Keywords
- Colon Cancer, Prognosis, Tumor-associated inflammatory adhesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 23 Oct 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 purpose of this study is to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients.
Detailed description
In some colon cancer patients, although adhesions between the tumor tissue and surrounding organs are found during surgery, postoperative pathology confirms that the tumor has not directly invaded the adhered organs; instead, the adhesions are caused by tumor-associated inflammation. This condition is defined as tumor-associated inflammatory adhesion.
Currently, the impact of tumor-associated inflammatory adhesion on patient prognosis is still unclear. This study aims to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients through the Surveillance, Epidemiology, and End Results (SEER) and Chinese multi-center databases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the U.S. National Cancer Center SEER database | – | Other: This was a retrospective study and no patient intervention was performed.SEER*Stat software (version 8.4.3) collected 17 registries cohort data on colon cancer patients between 2010 and 2019. |
| Chinese multi-center database | – | Other: This was a retrospective study and no patient intervention was performed.Chinese multi-center database includes patients from January 2010 to December 2021 at 3 institutions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study utilized the Chinese multi-center database as well as the SEER 17 registries database. The Chinese multi-center database contains data of patients between January 2010 and December 2021, at 3 institutions. SEER*Stat software (version 8.4.1.1) was used for collecting 17 registries cohort data on patients diagnosed with NMIBC between 2010 and 2019.
Key inclusion criteria (3 listed)
- The patient was pathologically diagnosed as colon adenocarcinoma by endoscopic biopsy before operation.
- All patients were considered to have tumors invading adjacent organs during surgery
- All patients underwent radical surgery.
Key exclusion criteria (1 listed)
- 1. Patients with distant metastasis, recurrent colon cancer and pT4b CRC were excluded.
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 |
|---|---|---|
| This was a retrospective study and no patient intervention was performed.This was a retrospective study and no patient intervention was performed. | Other | Chinese multi-center database, the U.S. National Cancer Center SEER database |
Primary outcome
Overall survival time (OS)
Time frame: up to 10 years
OS, defined as the time from the first diagnosis to death from any cause or the last follow-up for surviving patients
Cancer-specific survival time (CSS)
Time frame: up to 10 years
CSS refers to the duration from diagnosis of a tumor until the patient succumbs to the tumor, excluding deaths from other causes.
Recurrence free survival time (RFS)
Time frame: up to 10 years
RFS is the time from the time a patient achieved R0 resection after surgery to the time of recurrence or the end of follow-up.
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 7 Nov 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.
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 Colon Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 3 inclusion and 1 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 7 Nov 2024. 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?
Overall survival time (OS) (time frame: up to 10 years). 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 7 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.