Colon CancerNCT03794193
The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer
An observational study of Colon Cancer, run by Peking Union Medical College Hospital.
Trial summary
To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Radical resection of colon cancer
- Type of treatment
- Surgery or procedure
- How many people
- 1,367 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to Dec 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colon cancer patients with or without unfavorable histological features
Who may be able to join
- Age: 18-100 years old;
- Postoperative pathology confirmed colon adenocarcinoma;
- The tumor is located from the cecum to the sigmoid colon;
- No distant organ metastasis;
Who cannot join
- Simultaneous or metachronous multiple primary colorectal cancer;
- History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
- local excision procedure;
- palliative resection (R2 resection);
- pregnant or lactating women.
About this study
To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.
- Conditions
- Colon Cancer
- Being tested
- Radical resection of colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical resection of colon cancerProcedure or surgery
Also called Chemotherapy
The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Disease-free Survival
The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.
Measured: Within 3 years after surgery
Secondary outcomes (5)
3-year Over-all Survival
The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis.
Measured: Within 3 years after surgery
Postoperative complication rate
Measured: Within 30 days after surgery
Postoperative mortality rate
Measured: Within 30 days after surgery
Local recurrence rate
Measured: Within 3 years after surgery
Distant organ metastasis rate
Measured: Within 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jan 2016
- Primary completionDec 2020
- Study completionDec 2023 (estimated)
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 Colon CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 1,367 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, West China Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University First Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Yi Xiao, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794193
- Sponsor's protocol ID
- ZS-1653
- Status last verified
- Apr 2022
- First submitted
- 9 Sep 2018
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data can be shared with all researchers involved in the study.
Publications
Li K, Zhao F, Guo Y, Wu Q, Luo S, Zhang J, Li H, Hu S, Wu B, Lin G, Qiu H, Niu B, Sun X, Xu L, Lu J, Du X, Wang Z, Wang X, Kang L, Wang Z, Wang Q, Liu Q, Xiao Y. Interaction analysis of high-risk pathological features on adjuvant chemotherapy survival benefit in stage II colon cancer patients: a multi-center, retrospective study. BMC Cancer. 2023 Sep 18;23(1):797. doi: 10.1186/s12885-023-11196-4.
PubMed 37718392
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer
- ClinicalTrials.gov ID
- NCT03794193
- Acronym / sponsor ID
- ZS-1653
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,367 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, West China Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University First Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Jan 2019 (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.
To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colon cancer patients with or without unfavorable histological features
Key inclusion criteria (4 listed)
- Age: 18-100 years old;
- Postoperative pathology confirmed colon adenocarcinoma;
- The tumor is located from the cecum to the sigmoid colon;
- No distant organ metastasis;
Key exclusion criteria (5 listed)
- Simultaneous or metachronous multiple primary colorectal cancer;
- History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
- local excision procedure;
- palliative resection (R2 resection);
- pregnant or lactating women.
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 |
|---|---|---|
| Radical resection of colon cancerAlso: ChemotherapyThe patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results. | Procedure or surgery | – |
Primary outcome
3-year Disease-free Survival
Time frame: Within 3 years after surgery
The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.
5 secondary outcomes
3-year Over-all Survival
Time frame: Within 3 years after surgery
Postoperative complication rate
Time frame: Within 30 days after surgery
Postoperative mortality rate
Time frame: Within 30 days after surgery
Local recurrence rate
Time frame: Within 3 years after surgery
Distant organ metastasis rate
Time frame: Within 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 37718392Li K, Zhao F, Guo Y, Wu Q, Luo S, Zhang J, Li H, Hu S, Wu B, Lin G, Qiu H, Niu B, Sun X, Xu L, Lu J, Du X, Wang Z, Wang X, Kang L, Wang Z, Wang Q, Liu Q, Xiao Y. Interaction analysis of high-risk pathological features on adjuvant chemotherapy survival benefit in stage II colon cancer patients: a multi-center, retrospective study. BMC Cancer. 2023 Sep 18;23(1):797. doi: 10.1186/s12885-023-11196-4.
- Individual participant dataSharing planned: Undecided. Individual participant data can be shared with all researchers involved in the study.
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Colon Cancer
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.
Yi Xiao, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Peking Union Medical College Hospital.
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 5 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 4 May 2022. 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?
3-year Disease-free Survival (time frame: Within 3 years after 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 NCT03794193, 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 4 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.