Colorectal CancerNCT04707482
Mechanism and Process Regulation for Colorectal Tumors
An observational study of Colorectal Cancer and Adenoma, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
This study focused on the key nodes, molecular events and regulatory mechanisms of intestinal microecological disorders that affect the malignant transformation of intestinal epithelial cells into tumors during the occurrence and development of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Adenoma
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal adenoma; early colorectal cancer; familial genetic colorectal cancer who underwent colonoscopy and met diagnostic criteria; healthy controls group
Who may be able to join
- Inclusion Criteria（Healthy control group）： 1) Aged more than 18 years; 2) Planned to undergo colonoscopy , without past medical history of neoplasm or ulcer or bleeding under colonoscopy regardless of the history of colonoscopy; 3) Willing to participate in this trial and signed the informed consent.
- More than 18 years aged;
- Diagnosed as colorectal adenoma, epithelial adenomatoid hyperplasia, serrated lesions, or with mild to moderate dysplasia (low-grade intraepithelial neoplasia) by colonoscopy and pathology;
- Signed the informed consent, willing to participate in this trial.
- Inclusion Criteria（Sporadic early colorectal cancer group）：
- Aged more than 18 years;
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- Underwent endoscopic EMR/ESD or Surgical resection because of colorectal neoplasms and the lesion was confined to the mucosa or submucosa of the large intestine and was pathologically indicated to be adenocarcinoma;
- Willing to participate in this trial and signed the informed consent.
- Aged more than 18 years;
- Underwent ESD/EMR resection or surgical resection and the pathology result considered as early colorectal cancer and adenoma, and the family history, pathology and genetic tests met the diagnostic criteria of FAP and HNPCC/LS;
- Signed the informed consent, willing to participate in this trial. ·-Inclusion Criteria (Cohort study)
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- Aged 18-80 years;
- Diagnosed as polypoid neoplasm or lateral developmental neoplasm (LST) by endoscopy without a family history of CRC and the pathologic manifestations were conventional adenoma or serrated lesions; the patients without a family history of CRC underwent ESD or EMR resection and the pathology result considered as early colorectal cancer; diagnosed as sporadic colorectal early carcinoma and adenoma with a family history of colorectal cancer (FAP, Lynch syndrome);
- Signed the informed consent, willing to participate in this study and agreed with colonoscopy with pathology examination once a year and followed up for 5 years.
Who cannot join
- -Exclusion Criteria（Healthy control group）：
- With a medical history of digestive tract rerouting and partial resection;
- Patients with high risk of hereditary colorectal adenocarcinoma, i.e. family members of the following diseases: family history of gastrointestinal neoplasms, familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal adenocarcinoma (HNPCC/LS), and P-J syndrome;
- With A history of chronic metabolic and inflammatory diseases such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease and the chronic disease were difficult to control;
- With other malignancies known to have advanced or require treatment in the past 5 years, except basal cell and squamous cell carcinoma of the skin that have been radically cured;
- With a history of active gastrointestinal bleeding within the last 6 months;
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- With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;
- Received routine immunosuppressive drugs for the past 6 months;
- Unable or unwilling to cooperate with follow-up and related examinations;
- Patients who can not eat normally or need to rely on medicine or enema and other defecation;
- With mental illness or any other serious cardiovascular disease;
- With pregnant or lactating or planning to become pregnant within one year;
- Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.
- With a medical history of digestive tract rerouting and partial resection;
- Patients with high risk of hereditary colorectal adenocarcinoma, i.e. family members of the following diseases: family history of gastrointestinal neoplasms, familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal adenocarcinoma (HNPCC/LS), and P-J syndrome;
- With A history of chronic metabolic and inflammatory diseases such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease and the chronic disease were difficult to control;
- With other malignancies known to have advanced or require treatment in the past 5 years, except basal cell and squamous cell carcinoma of the skin that have been radically cured;
- With a history of active gastrointestinal bleeding within the last 6 months;
- With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;
- Received routine immunosuppressive drugs for the past 6 months;
- Unable or unwilling to cooperate with follow-up and related examinations;
- Patients who can not eat normally or need to rely on medicine or enema and other defecation;
- With mental illness or any other serious cardiovascular disease;
- With pregnant or lactating or planning to become pregnant within one year;
- Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.
- Exclusion Criteria（Sporadic early colorectal cancer group）：
- With a medical history of digestive tract rerouting and partial resection;
- Patients with high risk of hereditary colorectal adenocarcinoma, i.e. family members of the following diseases: family history of gastrointestinal neoplasms, familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal adenocarcinoma (HNPCC/LS), and P-J syndrome;
- With A history of chronic metabolic and inflammatory diseases such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease and the chronic disease were difficult to control;
- With other malignancies known to have advanced or require treatment in the past 5 years, except basal cell and squamous cell carcinoma of the skin that have been radically cured;
- With a history of active gastrointestinal bleeding within the last 6 months;
- With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;
- Received routine immunosuppressive drugs for the past 6 months;
- Unable or unwilling to cooperate with follow-up and related examinations;
- Patients who can not eat normally or need to rely on medicine or enema and other defecation;
- With mental illness or any other serious cardiovascular disease;
- With pregnant or lactating or planning to become pregnant within one year;
- Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.
- With a medical history of digestive tract rerouting and partial resection;
- With A history of chronic metabolic and inflammatory diseases such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease and the chronic disease were difficult to control;
- With a history of active gastrointestinal bleeding within the last 6 months;
- With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;
- Received routine immunosuppressive drugs for the past 6 months;
- Unable or unwilling to cooperate with follow-up and related examinations;
- Patients who can not eat normally or need to rely on medicine or enema and other defecation;
- With mental illness or any other serious cardiovascular disease;
- With pregnant or lactating or planning to become pregnant within one year;
- Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.
- Except baseline exclusion criteria, and the following conditions should be excluded:
- Diagnosed as advanced colorectal cancer (with or without surgery, radiation, chemotherapy, targeted therapy, immunotherapy);
- Refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospttal
Shanghai, Sahgnhai, 200000
Yanye Yang, Bachelor, +86-13636419858, young0503@163.com
About this study
Official title: Cohort Study of Mechanism and Process Regulation for Colorectal Tumors
This study focused on the key nodes, molecular events and regulatory mechanisms of intestinal microecological disorders that affect the malignant transformation of intestinal epithelial cells into tumors during the occurrence and development of colorectal cancer.
Read the detailed description
Phase Ⅰ is a cross-sectional study to record selected information and biospecimen of more than 250 sporadic colorectal adenoma cases (200 cases with convetional adenomas, 25 cases with hyperplasticpolyps and 25 cases with TSA/SSAs), 50 cases of sporadic colorectal cancer (early cancer), 50 cases with familial inherited colorectal cancer (FAP and LS) or healthy controls.
Phase Ⅱ is a nested case-control study. A total of 250 patients with sporadic colorectal cancer (early stage cancer) or sporadic colorectal adenoma will be included in Phase Ⅱ and regular follow-up to observe the recurrence and progress after resection of the lesions of colorectal adenomas.
The end point of the study is the recurrence of bowel adenoma or carcinoma and follow-up time is five years. After the observation, each case with the study outcome was matched with corresponding controls in a 1:1 ratio for further analysis according to the conditions such as age and gender.(Due to the particularity of single-cell sequencing, all specimens that meet the test requirements were sent for examination, and a nest-type case-control design was not adopted.)
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- Colorectal cancer, Adenoma, Mechanism, Process regulation
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of bacteria species
Difference of bacteria species between the recurrent and non recurrent colorectal adenomas.
Measured: May 1, 2022
Difference of metabolites of intestinal pathogenic bacteria
Difference of metabolites of intestinal pathogenic bacteria between the recurrent and non recurrent colorectal adenomas.
Measured: May 1, 2022
Difference of immune markers
Difference of immune markers between the recurrent and non recurrent colorectal adenomas.
Measured: May 31, 2023
Difference of protein expression
Difference of protein expression between the recurrent and non recurrent colorectal adenomas.
Measured: May 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2023 (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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, RenJi Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Sun Jing, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707482
- Sponsor's protocol ID
- mechanism for CRC
- Status last verified
- Mar 2021
- First submitted
- 12 Jan 2021
- Last updated
- 23 Mar 2021
- 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Mechanism and Process Regulation for Colorectal Tumors
- ClinicalTrials.gov ID
- NCT04707482
- Acronym / sponsor ID
- mechanism for CRC
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- Colorectal cancer, Adenoma, Mechanism, Process regulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, RenJi Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 13 Jan 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 study focused on the key nodes, molecular events and regulatory mechanisms of intestinal microecological disorders that affect the malignant transformation of intestinal epithelial cells into tumors during the occurrence and development of colorectal cancer.
Detailed description
Phase Ⅰ is a cross-sectional study to record selected information and biospecimen of more than 250 sporadic colorectal adenoma cases (200 cases with convetional adenomas, 25 cases with hyperplasticpolyps and 25 cases with TSA/SSAs), 50 cases of sporadic colorectal cancer (early cancer), 50 cases with familial inherited colorectal cancer (FAP and LS) or healthy controls.
Phase Ⅱ is a nested case-control study. A total of 250 patients with sporadic colorectal cancer (early stage cancer) or sporadic colorectal adenoma will be included in Phase Ⅱ and regular follow-up to observe the recurrence and progress after resection of the lesions of colorectal adenomas.
The end point of the study is the recurrence of bowel adenoma or carcinoma and follow-up time is five years. After the observation, each case with the study outcome was matched with corresponding controls in a 1:1 ratio for further analysis according to the conditions such as age and gender.(Due to the particularity of single-cell sequencing, all specimens that meet the test requirements were sent for examination, and a nest-type case-control design was not adopted.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal adenoma; early colorectal cancer; familial genetic colorectal cancer who underwent colonoscopy and met diagnostic criteria; healthy controls group
Key inclusion criteria (15 listed)
- Inclusion Criteria（Healthy control group）： 1) Aged more than 18 years; 2) Planned to undergo colonoscopy , without past medical history of neoplasm or ulcer or bleeding under colonoscopy regardless of the history of colonoscopy; 3) Willing to participate in this trial and signed the informed consent.
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Key exclusion criteria (51 listed)
- -Exclusion Criteria（Healthy control group）：
- Exclusion Criteria（Sporadic early colorectal cancer group）：
- Diagnosed as advanced colorectal cancer (with or without surgery, radiation, chemotherapy, targeted therapy, immunotherapy);
- Refuse to sign the informed consent.
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
Difference of bacteria species
Time frame: May 1, 2022
Difference of bacteria species between the recurrent and non recurrent colorectal adenomas.
Difference of metabolites of intestinal pathogenic bacteria
Time frame: May 1, 2022
Difference of metabolites of intestinal pathogenic bacteria between the recurrent and non recurrent colorectal adenomas.
Difference of immune markers
Time frame: May 31, 2023
Difference of immune markers between the recurrent and non recurrent colorectal adenomas.
Difference of protein expression
Time frame: May 31, 2023
Difference of protein expression between the recurrent and non recurrent colorectal adenomas.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
Sun Jing, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
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 and Adenoma, run by Shanghai Minimally Invasive Surgery Center 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 15 inclusion and 51 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 23 Mar 2021. 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?
Contact Sun Jing, PhD (13524284622, sj11788@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of bacteria species (time frame: May 1, 2022). 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 23 Mar 2021.