Colonic CancerCCCDNCT05434026
Chinese Colorectal Cancer Database
An observational study of Colonic Cancer and Rectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
1. To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China. 2. Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Cancer, Rectal Cancer, Prospective Studies
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to 22 Jun 2032
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: colorectal cancer patients who are suitable and willing to accept the surgery and also agree with the trial
Who may be able to join
- adenocarcinoma of the colon by biopsy
- tolerable to surgery
- be able to understand and willing to participate in this trial with signature
Who cannot join
- can not tolerate the surgery
- history of serious mental illness
- the researchers believe the patients should not enrolled in
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
Zhongtao Zhang
Beijing
Yishan Liu, 13065025613, LYSliuyishan613@163.com
About this study
- To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China.
- Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer.
- Provide academic consultation and data support to national health authorities.
- Conditions
- Colonic Cancer, Rectal Cancer, Prospective Studies
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate of circumferential resection margin (CRM) of the specimens
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
Measured: 10 days after surgery
The grade score of the specimens integrity
shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
Measured: 10 days after surgery
The distance between lower tumor margin and the lower reaction margin
shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
Measured: 10 days after surgery
local recurrence rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3 years after surgery
the operative time
preoperative safety containing operation information, complication information.
Measured: 30 days after surgery
postoperative hospital stay
recovery information.
Measured: 3 year after surgery
the score of postoperative life
quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.
Measured: 6 months after surgery
disease free survival rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3-year after surgery
overall survival rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3-year after surgery
the rate of postoperative complications
preoperative safety containing operation information, complication information.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start3 Aug 2022 (estimated)
- Primary completion22 Jun 2032 (estimated)
- Study completion22 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Peking Union Medical College Hospital, The First Hospital of Jilin University, Ruijin Hospital, First Hospital of China Medical University
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434026
- Sponsor's protocol ID
- CCCD
- Acronym
- CCCD
- Status last verified
- Aug 2022
- First submitted
- 22 Jun 2022
- Last updated
- 3 Aug 2022
- 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 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Colorectal Cancer Database
- ClinicalTrials.gov ID
- NCT05434026
- Acronym / sponsor ID
- CCCD / CCCD
- Conditions
- Colonic Cancer, Rectal Cancer, Prospective Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Peking Union Medical College Hospital, The First Hospital of Jilin University, Ruijin Hospital, First Hospital of China Medical University
- Study start
- 3 Aug 2022 (estimated)
- Primary completion
- 22 Jun 2032 (estimated)
- Study completion
- 22 Jun 2032 (estimated)
- First posted
- 27 Jun 2022 (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 establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China.
- Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer.
- Provide academic consultation and data support to national health authorities.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- colorectal cancer patients who are suitable and willing to accept the surgery and also agree with the trial
Key inclusion criteria (3 listed)
- adenocarcinoma of the colon by biopsy
- tolerable to surgery
- be able to understand and willing to participate in this trial with signature
Key exclusion criteria (3 listed)
- can not tolerate the surgery
- history of serious mental illness
- the researchers believe the patients should not enrolled in
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
Positive rate of circumferential resection margin (CRM) of the specimens
Time frame: 10 days after surgery
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
The grade score of the specimens integrity
Time frame: 10 days after surgery
shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
The distance between lower tumor margin and the lower reaction margin
Time frame: 10 days after surgery
shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
local recurrence rate
Time frame: 3 years after surgery
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
the operative time
Time frame: 30 days after surgery
preoperative safety containing operation information, complication information.
postoperative hospital stay
Time frame: 3 year after surgery
recovery information.
the score of postoperative life
Time frame: 6 months after surgery
quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.
disease free survival rate
Time frame: 3-year after surgery
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
overall survival rate
Time frame: 3-year after surgery
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
the rate of postoperative complications
Time frame: 30 days after surgery
preoperative safety containing operation information, complication information.
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 3 Aug 2022.
Related trials for Colonic Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung 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.
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 Colonic Cancer and Rectal 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 3 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 3 Aug 2022. 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 (13801060364, zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive rate of circumferential resection margin (CRM) of the specimens (time frame: 10 days after surgery). The study lists 10 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 3 Aug 2022.