Status:
UNKNOWN
Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
Lead Sponsor:
Shanghai Minimally Invasive Surgery Center
Collaborating Sponsors:
Shanghai Municipal Science and Technology Commission
RenJi Hospital
Conditions:
Colorectal Cancer Stage III
Colorectal Cancer Stage IV
Eligibility:
All Genders
18-75 years
Brief Summary
This is a two stage nested case-control study to construct the hologram plane , explore biomarkers and screening original drugs of metastatic colorectal cancer.
Detailed Description
Stage Ⅰ is a cross-sectional study to record selected information and biospecimen of more than 200 colorectal cancer cases( at least 160 stage Ⅲ cases,40 stage Ⅳ（synchronous metastasis）).Stage Ⅱ is a ...
Eligibility Criteria
Inclusion
- Baseline population (stage III colorectal cancer) inclusion criteria:
- Aged 18-75.
- Physical condition (ECOG) score ≤ 1.
- Colorectal adenocarcinoma was confirmed by histopathology.
- No family history of hereditary tumor.
- Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
- Preoperative clinical stage is stage III.
- Agree to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
- Enough primary surgical or biopsy tissues for examination.
- Enough peripheral blood samples for examination.
- Agree to sign informed consent to participate in this project.
- Baseline population (stage Ⅳ colorectal cancer) inclusion criteria:
- Aged 18-75.
- Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV.
- Not yet received antineoplastic therapy.
- Baseline imaging evaluation shows at least one measurable focus.
- Sufficient primary surgical or biopsy tissues and metastatic tissues of at least one organ for examination.
- Enough peripheral blood samples for examination.
- Expected survival time ≥ 3 months.
- Provide information such as demography, current medical history or current tumor disease, pathological diagnosis and staging of tumor, physical status of ECOG, radiographic evaluation of tumor, etc.
- Agree to sign informed consent to participate in this project.
- Metastasis colorectal cancer cohort study inclusion criteria:
- Aged 18-75.
- Physical condition (ECOG) score ≤ 1.
- Colorectal adenocarcinoma was confirmed by histopathology.
- No family history of hereditary tumor.
- Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
- Preoperative clinical stage is stage III and the postoperative pathological stage was confirmed as stage III.
- Agreed to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
- Enough primary surgical or biopsy tissues for examination.
- Enough peripheral blood samples for examination.
- Agree to sign informed consent to participate in this project.
Exclusion
- Baseline population (stage III colorectal cancer) exclusion criteria:
- Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
- Postoperative pathological stage was confirmed as stage II.
- Abnormal function of heart, lung, liver, kidney, hematopoiesis or bone marrow reserve, which cannot tolerate operation or chemotherapy.
- Diagnosed with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
- Having mental illness or other serious cardiovascular diseases.
- Pregnancy or lactation or planned pregnancy within one year.
- Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
- Baseline population (stage Ⅳcolorectal cancer) exclusion criteria:
- Family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, P-J syndrome, etc.
- Nervous system metastasis.
- Complicated with other malignant tumors.
- Having poorly controlled chronic concomitant diseases that affect the prognosis.
- Any complication that may affect the results of the study .
- Metastasis colorectal cancer cohort study exclusion criteria:
- Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
- Abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which cannot tolerate operation and chemotherapy.
- Diagnoses with malignant tumors that have progressed or need to be treated in the past 5 years, except for cured skin basal cells and skin squamous cell carcinoma.
- Having mental illness or other serious cardiovascular disease.
- Pregnancy or lactation or planned pregnancy within one year.
- Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04714814
Start Date
June 1 2021
End Date
May 1 2023
Last Update
March 23 2021
Active Locations (1)
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1
Shanghai Ruijin Hospttal
Shanghai, Sahgnhai, China, 200000