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Multicenter clinical validation of a new paradigm for early diagnosis and recurrence monitoring

Multicenter clinical validation of a new paradigm for early diagnosis and recurrence monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104818
Enrollment
Unknown
Registered
2025-06-24
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Index test:Methylation sequencing, transcriptome sequencing, proteome, metabolome

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for case groups: (1) Age between 18-80 years old, gender is not limited; (2) Patients diagnosed with early-stage colorectal cancer in our hospital, the specific criteria are as follows: a) Meet the diagnostic criteria of the National Health Commission of the People's Republic of China for the diagnosis and treatment of colorectal cancer in China (2023 Edition), and be diagnosed as primary colorectal cancer by pathological tissue examination based on the imaging features of endoscopy, CT/CT enhanced scan or MRI; b) Evaluated by the American Joint Committee Cancer (AJCC)/Union for International Cancer Control (UICC) Colorectal Cancer TNM Staging System (8th Edition, 2017) as stage I or II colorectal cancer (T1-4N0M0); c) Have not received chemotherapy and radiotherapy, immunotherapy, surgery, etc.; (3) No previous history of other malignant tumors; (4) Signed informed consent; 2. Inclusion criteria for controlled study participants with no obvious abnormalities in colonoscopy: (1) Age between 18-80 years old, gender is not limited; (2) There was no abnormality in the results of colonoscopy in the past 3 months; (3) No history of malignant tumors, no family history of malignant tumors (first-degree relatives are parents and/or second-degree relatives, i.e., grandfathers, grandmothers, uncles, etc., who do not have malignant tumors); (4) No obesity, hypertension, hyperlipidemia, metabolic syndrome and other diseases, no excessive drinking and other bad lifestyle habits; (5) Voluntarily sign the informed consent form and be able to strictly follow the trial protocol to complete the study; 3. Inclusion Criteria for Patients with Non-neoplastic Bowel Diseases: (1) Age between 18-80 years old, gender is not limited; (2) Patients diagnosed with colorectal adenoma, inflammatory bowel disease and other non-neoplastic intestinal diseases through colonoscopy and pathological examination, and have no history of colorectal cancer in the past. 4. Inclusion criteria for patients with non-intestinal malignancies: (1) Age between 18-80 years old, gender is not limited; (2) Meet the latest version of the diagnostic criteria of the National Health Commission of the People's Republic of China or the Chinese Medical Association, and be diagnosed as gastric cancer, liver cancer, pancreatic cancer, esophageal cancer and other non-intestinal malignant tumors by pathological tissue examination according to the imaging characteristics of endoscopy, CT/CT enhanced scanning or MRI, combined with clinical manifestations and relevant laboratory examinations. Have not received chemotherapy and radiotherapy, immunotherapy, surgery, etc. No previous history of colorectal cancer. 5. Inclusion Criteria for Chemotherapy Resistance Prediction Cohort: (1) Age between 18-80 years old, gender is not limited; (2) Patients diagnosed with colorectal cancer in our hospital, the specific criteria are as follows: a) Meet the diagnostic criteria of the National Health Commission of the People's Republic of China for the diagnosis and treatment of colorectal cancer in China (2023 Edition), and be diagnosed as primary colorectal cancer by pathological tissue examination based on the imaging features of endoscopy, CT/CT enhanced scan or MRI; b) Evaluated by the American Joint Committee Cancer (AJCC)/Union for International Cancer Control (UICC) Colorectal Cancer TNM Staging System (8th Edition, 2017) as assessed for stage II or III colorectal cancer (T1-4N1-2M0); c)

Exclusion criteria

Exclusion criteria: 1. Severe comorbidities, such as liver and kidney insufficiency, etc. (Child-Pugh grade C or eGFR=200 mL in the past 2 months, and have had blood transfusion or use blood products in the past 2 months; 5. Those who have participated in the clinical trial of any drug or medical device in the past 3 months or the investigational drug has not exceeded 5 half-lives (whichever is longer); 6. Inability to cooperate with follow-up (such as mental illness, expected survival < 1 year); 7. Withdrawal or loss to follow-up during the study; 8. Incomplete information of study participants.

Design outcomes

Primary

MeasureTime frame
Plasma cfDNA sequencing;Plasma metabolome;Plasma methylation sequencing;Serum tumor markers;Plasma cfRNA sequencing;Serum protein profile;

Countries

China

Contacts

Public ContactJie Liu

Huashan Hospital, Fudan University

jieliu@fudan.edu.cn+86 21 52888236

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026