Adenoma, Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Adenoma, Mechanism, Process regulation
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.)
Interventions
None listed
Sponsors
Shanghai Municipal Science and Technology Commission
RenJi Hospital
Shanghai Jiao Tong University School of Medicine
Shanghai Minimally Invasive Surgery Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Inclusion Criteria（Sporadic colorectal adenoma group）： 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. * Inclusion Criteria（Sporadic early colorectal cancer group）： 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. * Inclusion Criteria（Familial colorectal neoplasm group）： 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; 3. Signed the informed consent, willing to participate in this trial. ·-Inclusion Criteria (Cohort study) <!-- --> 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
* -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of bacteria species | May 1, 2022 | Difference of bacteria species between the recurrent and non recurrent colorectal adenomas. |
| Difference of metabolites of intestinal pathogenic bacteria | May 1, 2022 | Difference of metabolites of intestinal pathogenic bacteria between the recurrent and non recurrent colorectal adenomas. |
| Difference of immune markers | May 31, 2023 | Difference of immune markers between the recurrent and non recurrent colorectal adenomas. |
| Difference of protein expression | May 31, 2023 | Difference of protein expression between the recurrent and non recurrent colorectal adenomas. |
Countries
China
Contacts
Primary ContactSun Jing, PhD
Outcome results
None listed