Mechanism and Process Regulation for Colorectal Tumors

NCT ID: NCT04707482

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-05-01

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. More than 18 years aged;

2. Diagnosed as colorectal adenoma, epithelial adenomatoid hyperplasia, serrated lesions, or with mild to moderate dysplasia (low-grade intraepithelial neoplasia) by colonoscopy and pathology;

3. Signed the informed consent, willing to participate in this trial.

1. Aged more than 18 years;

2. 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;

3. Willing to participate in this trial and signed the informed consent.

1. Aged more than 18 years;

2. 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;

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1. Aged 18-80 years;

2. 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);

3. 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.

Exclusion Criteria

1. With a medical history of digestive tract rerouting and partial resection;

2. 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;

3. 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;

4. 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;

5. With a history of active gastrointestinal bleeding within the last 6 months;

6. With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;

7. Received routine immunosuppressive drugs for the past 6 months;

8. Unable or unwilling to cooperate with follow-up and related examinations;

9. Patients who can not eat normally or need to rely on medicine or enema and other defecation;

10. With mental illness or any other serious cardiovascular disease;

11. With pregnant or lactating or planning to become pregnant within one year;

12. Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.

1. With a medical history of digestive tract rerouting and partial resection;

2. 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;

3. 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;

4. 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;

5. With a history of active gastrointestinal bleeding within the last 6 months;

6. With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;

7. Received routine immunosuppressive drugs for the past 6 months;

8. Unable or unwilling to cooperate with follow-up and related examinations;

9. Patients who can not eat normally or need to rely on medicine or enema and other defecation;

10. With mental illness or any other serious cardiovascular disease;

11. With pregnant or lactating or planning to become pregnant within one year;

12. Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.

1. With a medical history of digestive tract rerouting and partial resection;

2. 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;

3. 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;

4. 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;

5. With a history of active gastrointestinal bleeding within the last 6 months;

6. With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;

7. Received routine immunosuppressive drugs for the past 6 months;

8. Unable or unwilling to cooperate with follow-up and related examinations;

9. Patients who can not eat normally or need to rely on medicine or enema and other defecation;

10. With mental illness or any other serious cardiovascular disease;

11. With pregnant or lactating or planning to become pregnant within one year;

12. Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.

1. With a medical history of digestive tract rerouting and partial resection;

2. 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;

3. With a history of active gastrointestinal bleeding within the last 6 months;

4. With a history of using broad-spectrum antibiotics and probiotics by oral or intravenous within the past 1 month;

5. Received routine immunosuppressive drugs for the past 6 months;

6. Unable or unwilling to cooperate with follow-up and related examinations;

7. Patients who can not eat normally or need to rely on medicine or enema and other defecation;

8. With mental illness or any other serious cardiovascular disease;

9. With pregnant or lactating or planning to become pregnant within one year;

10. Currently participating in, or receiving, an interventional clinical study that affects patients' treatment decisions.

1. Diagnosed as advanced colorectal cancer (with or without surgery, radiation, chemotherapy, targeted therapy, immunotherapy);

2. Refuse to sign the informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Science and Technology Commission

OTHER_GOV

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun Jing, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sun Jing, PhD

Role: CONTACT

sj11788@rjh.com.cn

13524284622

Facility Contacts

Yanye Yang, Bachelor

Role: primary

young0503@163.com

+86-13636419858

Other Identifiers

mechanism for CRC

Identifier Type: -

Identifier Source: org_study_id