Colorectal CancerNCT05015296
The Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer
An observational study of Colorectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a multi-center, prospective, non-interventional real-world study. In a real-world environment, in line with the current status of the domestic diagnosis and treatment process, and on the premise of not increasing the burden of patients and medical resources, we explore the best indicators for predicting the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 7,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * 18-85 years old, regardless of gender; * Patients with newly diagnosed CRC who are planned to undergo surgery (including patients with metastases but still feasible for surgery); * Patients who have not been diagnosed for the first time and have not received surgical treatment and now planned to undergo surgery(e.g., patients after neoadjuvant radiotherapy and chemotherapy for middle and low rectal cancer).
Who may be able to join
- 18-85 years old, regardless of gender;
- Patients with newly diagnosed CRC who are planned to undergo surgery (including patients with metastases but still feasible for surgery);
- Patients who have not been diagnosed for the first time and have not received surgical treatment and now planned to undergo surgery(e.g., patients after neoadjuvant radiotherapy and chemotherapy for middle and low rectal cancer).
Who cannot join
- Patients who refused to sign informed consent;
- Patients complicated with other tumors;
- Pregnant or lactating women;
- People with a history of psychotropic drug abuse and unable to quit or those with mental disorders;
- Postoperative histopathological examinations for patients with non-CRC type;
- Patients who could not be followed up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Frendship Hospital
Beijing, Beijing Municipality
Zhongtao Professor, 86-010-63138217, zhangzht@ccmu.edu.cn
About this study
Official title: A Multicenter, Prospective, Non-interventional Real-world Study of the Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer
This is a multi-center, prospective, non-interventional real-world study. In a real-world environment, in line with the current status of the domestic diagnosis and treatment process, and on the premise of not increasing the burden of patients and medical resources, we explore the best indicators for predicting the outcome of patients with Clinical Research Coordinator (CRC) after surgery. The inclusion criteria for patients are perioperative patients with CRC. Real-world data analysis were conducted to determine whether immunization interventions versus non-interventions were able to improve patients' clinical outcomes (OS, PFS).
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Immune Cells
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of immune cells in patients before and after surgery
Preoperative lymphocyte count, postoperative lymphocyte count and normal time, recovery time.
Measured: Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days
1-year overall survival after surgery
the percentage of patients who survived in all patients evaluated at 1 year after surgery
Measured: Postoperative 1 year
1-year disease-free survival after surgery
the percentage of patients who survived disease-free in all patients evaluated at 1 year after surgery
Measured: Postoperative 1 year
1-year recurrence-free survival after surgery
the percentage of patients who survived without recurrence in all patients evaluated at 1 year after surgery
Measured: Postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start23 Nov 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2030 (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.
- More trials run by Beijing Friendship 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015296
- Sponsor's protocol ID
- BFH-RWS-CRC
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2021
- Last updated
- 20 Jul 2026
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-interventional Real-world Study of the Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05015296
- Acronym / sponsor ID
- BFH-RWS-CRC
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Immune Cells
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Aug 2021 (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 is a multi-center, prospective, non-interventional real-world study. In a real-world environment, in line with the current status of the domestic diagnosis and treatment process, and on the premise of not increasing the burden of patients and medical resources, we explore the best indicators for predicting the outcome of patients with Clinical Research Coordinator (CRC) after surgery. The inclusion criteria for patients are perioperative patients with CRC. Real-world data analysis were conducted to determine whether immunization interventions versus non-interventions were able to improve patients' clinical outcomes (OS, PFS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 18-85 years old, regardless of gender; * Patients with newly diagnosed CRC who are planned to undergo surgery (including patients with metastases but still feasible for surgery); * Patients who have not been diagnosed for the first time and have not received surgical treatment and now planned to undergo surgery(e.g., patients after neoadjuvant radiotherapy and chemotherapy for middle and low rectal cancer).
Key inclusion criteria (3 listed)
- 18-85 years old, regardless of gender;
- Patients with newly diagnosed CRC who are planned to undergo surgery (including patients with metastases but still feasible for surgery);
- Patients who have not been diagnosed for the first time and have not received surgical treatment and now planned to undergo surgery(e.g., patients after neoadjuvant radiotherapy and chemotherapy for middle and low rectal cancer).
Key exclusion criteria (6 listed)
- Patients who refused to sign informed consent;
- Patients complicated with other tumors;
- Pregnant or lactating women;
- People with a history of psychotropic drug abuse and unable to quit or those with mental disorders;
- Postoperative histopathological examinations for patients with non-CRC type;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of immune cells in patients before and after surgery
Time frame: Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days
Preoperative lymphocyte count, postoperative lymphocyte count and normal time, recovery time.
1-year overall survival after surgery
Time frame: Postoperative 1 year
the percentage of patients who survived in all patients evaluated at 1 year after surgery
1-year disease-free survival after surgery
Time frame: Postoperative 1 year
the percentage of patients who survived disease-free in all patients evaluated at 1 year after surgery
1-year recurrence-free survival after surgery
Time frame: Postoperative 1 year
the percentage of patients who survived without recurrence in all patients evaluated at 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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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.
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 Colorectal Cancer, run by Beijing Friendship Hospital 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 6 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongtao Zhang, doctor (13801060364 ext. 010-63138217, zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of immune cells in patients before and after surgery (time frame: Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days). The study lists 4 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 20 Jul 2026.