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Establishment and clinical validation of molecular marker spectrum for diagnosis and treatment of colorectal cancer

Establishment and clinical validation of molecular marker spectrum for diagnosis and treatment of colorectal cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076831
Enrollment
Unknown
Registered
2023-10-20
Start date
2022-01-20
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Colorectal cancer

Interventions

Healthy volunteer:N/A
Colorectal cancer patients:N/A
High-risk groups for colorectal cancer:N/A

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.1 CRC patients standard constrain: (1) Age =18 years old and =80 years old; (2) The patient was diagnosed with colorectal cancer by colonoscopy and biopsy before surgery, and had resectable lesions; (3) No distant metastases were confirmed by imaging before surgery; (4) All patients underwent colorectal resection + regional lymph node dissection, and postoperative pathological specimens were re-confirmed as colorectal cancer; (5) According to the UICC/AJCC TNM staging system (8th edition in 2017), the postoperative pathological staging was stage I-III. (6) The ability to sign informed consent. 1.2 Healthy subjects Aged =18 years old and =80 years old, no obvious complaints, physical examination in Beijing Hospital confirmed that he was healthy, no lung tumor was found in chest X-ray and/or CT scan, and no liver, gallbladder, kidney, pancreas, bladder, Pelvic and thyroid tumors, B-ultrasound of female subjects excluded breast tumors, and serum tumor markers were normal. 1.3 High-risk patients with CRC Seeing a doctor in the Department of Gastroenterology of Beijing Hospital, intending to undergo endoscopy, aged =18 years old and =80 years old. Those who meet one or more of the following are classified as high-risk groups (for the standard, refer to the Expert Consensus on Early Diagnosis and Screening Strategies for Colorectal Tumors in China): (1) First-degree relatives have a history of colorectal cancer; (2) I have a history of cancer (any history of malignant tumors); (3) I have a history of intestinal polyps; (4) Have two or more of the following at the same time: A. Chronic constipation (constipation for more than 2 months per year in the past two years); B. Chronic diarrhea (diarrhea that has lasted for more than 3 months in the past two years, and each episode lasts for 1 week or more); C. Mucus and bloody stool; D. History of adverse life events (occurring within the past 20 years, and causing greater mental trauma or pain to the respondents after the event); E. History of chronic appendicitis or appendectomy; F. History of chronic biliary disease or cholecystectomy.

Exclusion criteria

Exclusion criteria: 1.1 CRC patients Exclusion criteria: (1) Surgery history within the past 5 years; (2) Those who have received chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, cytokine therapy, or biological agent therapy before surgery. (3) Patients with second primary tumor; (4) Systemic infection and inflammation, such as lung, gastrointestinal tract, pancreas, hepatobiliary system, abdominal cavity, urogenital system, skin and soft tissue, nervous system, endocardium, pericardium, periodontal, bloodstream infection. (5) Patients with inflammatory bowel disease and colorectal polyps; (6) Serious internal organ complications; (7) Those who are pregnant, lactating, and mentally ill. 1.2 Healthy subjects Exclusion criteria: (1) Those who are pregnant, breastfeeding, or mentally ill; (2) Those with a history of cancer; (3) Family history of colorectal cancer in first-degree relatives; (4) Systemic infection or inflammation: lung, gastrointestinal tract, pancreas, hepatobiliary system, abdominal cavity, urogenital system, skin and soft tissue, nervous system, endocardium, pericardium, periodontal, bloodstream infection. (5) History of inflammatory bowel disease and colorectal polyps; (6) History of surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, cytokine therapy, and biological agent therapy within the past 5 years; (7) Serious internal organ complications.

Design outcomes

Primary

MeasureTime frame
To screen the related diagnostic markers of colorectal cancer;

Countries

China

Contacts

Public ContactJie Ma

Beijing Hospital

liucxmm@126.com+86 10 8513 3662

Outcome results

None listed

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