Mechanism and Process Regulation for Colorectal Tumors

NCT04707482 | Unknown

• 1 other identifier: mechanism for CRC
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Adenoma

Keywords

Colorectal cancer; Adenoma; Mechanism; Process regulation

Outcome Measures

Primary Outcomes (4)

• Difference of bacteria species

  Difference of bacteria species between the recurrent and non recurrent colorectal adenomas.

  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.

  May 1, 2022

• Difference of immune markers

  Difference of immune markers between the recurrent and non recurrent colorectal adenomas.

  May 31, 2023

• Difference of protein expression

  Difference of protein expression between the recurrent and non recurrent colorectal adenomas.

  May 31, 2023

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal adenoma; early colorectal cancer; familial genetic colorectal cancer who underwent colonoscopy and met diagnostic criteria; healthy controls group

You may qualify if:

• 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.
• Aged more than 18 years;
• 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;
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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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead
• Shanghai Municipal Science and Technology Commission: collaborator
• RenJi Hospital: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, 200000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample, blood sample, stool sample

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Sun Jing, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Jing, PhD

CONTACT

13524284622; sj11788@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CN (1)