Mechanisms of Fate Evolution of Colorectal Adenocarcinoma Metastasis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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 nested case-control study. 200 eligible cases enrolled in phaseⅠwill be followed up for 5 years to record recurrence, metastasis and to collect biospecimen . Each case with the study outcome will be matched with the corresponding control according to the proportion of 1:1 according to age, sex and other conditions, and further analysis will be made.
Study Design
Outcome Measures
Primary Outcome Measures
- recurrence or metastasis provened by imageologic diagnosis (PFS) [May 31, 2023]
tumor metastasis or progression occurred during the enrolment period
Eligibility Criteria
Criteria
Inclusion Criteria:
- Baseline population (stage III colorectal cancer) inclusion criteria:
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Aged 18-75.
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Physical condition (ECOG) score ≤ 1.
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Colorectal adenocarcinoma was confirmed by histopathology.
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No family history of hereditary tumor.
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Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
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Preoperative clinical stage is stage III.
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Agree to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
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Enough primary surgical or biopsy tissues for examination.
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Enough peripheral blood samples for examination.
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Agree to sign informed consent to participate in this project.
Baseline population (stage Ⅳ colorectal cancer) inclusion criteria:
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Aged 18-75.
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Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV.
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Not yet received antineoplastic therapy.
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Baseline imaging evaluation shows at least one measurable focus.
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Sufficient primary surgical or biopsy tissues and metastatic tissues of at least one organ for examination.
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Enough peripheral blood samples for examination.
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Expected survival time ≥ 3 months.
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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.
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Agree to sign informed consent to participate in this project.
Metastasis colorectal cancer cohort study inclusion criteria:
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Aged 18-75.
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Physical condition (ECOG) score ≤ 1.
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Colorectal adenocarcinoma was confirmed by histopathology.
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No family history of hereditary tumor.
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Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12.
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Preoperative clinical stage is stage III and the postoperative pathological stage was confirmed as stage III.
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Agreed to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months.
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Enough primary surgical or biopsy tissues for examination.
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Enough peripheral blood samples for examination.
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Agree to sign informed consent to participate in this project.
Exclusion Criteria:
- Baseline population (stage III colorectal cancer) exclusion criteria:
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Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
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Postoperative pathological stage was confirmed as stage II.
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Abnormal function of heart, lung, liver, kidney, hematopoiesis or bone marrow reserve, which cannot tolerate operation or chemotherapy.
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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.
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Having mental illness or other serious cardiovascular diseases.
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Pregnancy or lactation or planned pregnancy within one year.
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Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
Baseline population (stage Ⅳcolorectal cancer) exclusion criteria:
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Family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, P-J syndrome, etc.
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Nervous system metastasis.
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Complicated with other malignant tumors.
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Having poorly controlled chronic concomitant diseases that affect the prognosis.
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Any complication that may affect the results of the study .
Metastasis colorectal cancer cohort study exclusion criteria:
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Participating in interventional clinical studies or receiving research treatments that influence patients' treatment decisions.
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Abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which cannot tolerate operation and chemotherapy.
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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.
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Having mental illness or other serious cardiovascular disease.
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Pregnancy or lactation or planned pregnancy within one year.
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Emergency operation (perforation, bleeding, intestinal obstruction, etc.).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Ruijin Hospttal | Shanghai | Sahgnhai | China | 200000 |
Sponsors and Collaborators
- Shanghai Minimally Invasive Surgery Center
- Science and Technology Commission of Shanghai Municipality
- RenJi Hospital
- Shanghai Jiao Tong University School of Medicine
Investigators
- Principal Investigator: Sun Jing, PhD, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Metastatic CRC cell fate