Colorectal CancerNCT06423924
Second Primary Cancer and Early-onset Colorectal Cancer
An observational study of Colorectal Cancer and Second Primary Cancer, run by LI XIN-XIANG.
Trial summary
The objective of this study was to analyze the pathological factors influencing the occurrence and prognosis of SPC in CRC patients of varying ages and compare the differences in the patterns of SPC occurrence and prognosis among patients of different age groups. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Second Primary Cancer
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2024to 1 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients retrieved from the database of Fudan University Shanghai Cancer Center. These patients were diagnosed with CRC primary tumors between January 2008 and December 2018.
Who may be able to join
- Patients undergoing radical surgery for colorectal cancer at Fudan University Shanghai Cancer Center between January 2008 and December 2018.
- Stage Ⅰ-Ⅳ colorectal cancer confirmed by clear pathological information
Who cannot join
- Previous history of other cancers before surgery
- Patients under 18 years old or over 80 years old
About this study
Official title: Risk Factors, Cancer Types and Prognostic Significance of Second Primary Cancer Based on the Early-onset and Late-onset Colorectal Cancer
The objective of this study was to analyze the pathological factors influencing the occurrence and prognosis of SPC in CRC patients of varying ages and compare the differences in the patterns of SPC occurrence and prognosis among patients of different age groups.
- Conditions
- Colorectal Cancer, Second Primary Cancer
- Being tested
- no intervention
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| <50 years | Not described Receives: Other: no intervention | |
| 50-69 years | Not described Receives: Other: no intervention | |
| ≥70 years | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first.
Up to 100 months
Measured: The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first. 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 posted21 May 2024
- Study start11 May 2024 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LI XIN-XIANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LI XIN-XIANG, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423924
- Sponsor's protocol ID
- CRCSPM
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Cancer Types and Prognostic Significance of Second Primary Cancer Based on the Early-onset and Late-onset Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06423924
- Acronym / sponsor ID
- CRCSPM
- Conditions
- Colorectal Cancer, Second Primary Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- LI XIN-XIANGUniversity, hospital or other
- Study start
- 11 May 2024 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 21 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.
The objective of this study was to analyze the pathological factors influencing the occurrence and prognosis of SPC in CRC patients of varying ages and compare the differences in the patterns of SPC occurrence and prognosis among patients of different age groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| <50 years | – | Other: no intervention |
| 50-69 years | – | Other: no intervention |
| ≥70 years | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients retrieved from the database of Fudan University Shanghai Cancer Center. These patients were diagnosed with CRC primary tumors between January 2008 and December 2018.
Key inclusion criteria (2 listed)
- Patients undergoing radical surgery for colorectal cancer at Fudan University Shanghai Cancer Center between January 2008 and December 2018.
- Stage Ⅰ-Ⅳ colorectal cancer confirmed by clear pathological information
Key exclusion criteria (2 listed)
- Previous history of other cancers before surgery
- Patients under 18 years old or over 80 years old
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 |
|---|---|---|
| no interventionno intervention | Other | 50-69 years, <50 years, ≥70 years |
Primary outcome
overall survival
Time frame: The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first. Up to 100 months
The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first. 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 21 May 2024.
- Individual participant dataSharing planned: No
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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 Colorectal Cancer and Second Primary Cancer, run by LI XIN-XIANG.
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 2 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: status not confirmed, as of the sponsor's last update on 21 May 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?
overall survival (time frame: The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first. 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 21 May 2024.