PrognosisNCT06416501
The Impact of Colorectal Cancer Screening on Surgical Outcomes
An observational study of Prognosis and Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to investigate the pathological characteristics and surgical outcomes of stage III CRC patients detected through screening. Data extracted from the database included the following patient information: age at diagnosis, gender, tumor location, neoadjuvant therapy, surgical procedures, histologic type… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prognosis, Colorectal Cancer, Screening
- What is being tested?
- Mode of detection
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2024to 15 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent surgical intervention for CRC at Fudan University Shanghai Cancer Center.
Who may be able to join
- Patients who underwent radical surgery for CRC, had confirmed stage III CRC through postoperative pathology, had no prior history of cancer before surgery, and had clear cancer detection information.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the pathological characteristics and surgical outcomes of stage III CRC patients detected through screening.
Data extracted from the database included the following patient information: age at diagnosis, gender, tumor location, neoadjuvant therapy, surgical procedures, histologic type, differentiation, vascular invasion, perineural invasion, pathological T stage, pathological N stage, and survival outcomes.
- Conditions
- Prognosis, Colorectal Cancer, Screening
- Being tested
- Mode of detection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mode of detectionOther
Mode of detection
| Study group | Role | What they receive |
|---|---|---|
| screening | Patients who were detected through any screening test were categorized into the screening group Receives: Other: Mode of detection | |
| nonscreening | Patients who were detected based on symptoms formed the non-screening group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first.
Assessed up to 100 months.
Measured: the duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first. Assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start11 May 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrognosisStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI XIN-XIANG, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416501
- Sponsor's protocol ID
- FudanUcf
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Colorectal Cancer Screening on Surgical Outcomes
- ClinicalTrials.gov ID
- NCT06416501
- Acronym / sponsor ID
- FudanUcf
- Conditions
- Prognosis, Colorectal Cancer, Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 May 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 16 May 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.
This study aims to investigate the pathological characteristics and surgical outcomes of stage III CRC patients detected through screening.
Data extracted from the database included the following patient information: age at diagnosis, gender, tumor location, neoadjuvant therapy, surgical procedures, histologic type, differentiation, vascular invasion, perineural invasion, pathological T stage, pathological N stage, and survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screening | – | Other: Mode of detectionPatients who were detected through any screening test were categorized into the screening group |
| nonscreening | – | –Patients who were detected based on symptoms formed the non-screening group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent surgical intervention for CRC at Fudan University Shanghai Cancer Center.
Key inclusion criteria (1 listed)
- Patients who underwent radical surgery for CRC, had confirmed stage III CRC through postoperative pathology, had no prior history of cancer before surgery, and had clear cancer detection information.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mode of detectionMode of detection | Other | screening |
Primary outcome
overall survival
Time frame: the duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first. Assessed up to 100 months.
The duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first. Assessed up to 100 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Yes
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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 Prognosis and Colorectal Cancer, run by Fudan 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 1 inclusion and 0 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 16 May 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?
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?
overall survival (time frame: the duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first. Assessed up to 100 months.). 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 16 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.