Colorectal Cancer Stage III, Colorectal Cancer Stage IV
Conditions
Keywords
Colorectal , Metastatisis ,Cancer Cell Fate Regulatory Mechanism
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 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.
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
* Baseline population (stage III colorectal cancer) inclusion criteria: 1. Aged 18-75. 2. Physical condition (ECOG) score ≤ 1. 3. Colorectal adenocarcinoma was confirmed by histopathology. 4. No family history of hereditary tumor. 5. Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12. 6. Preoperative clinical stage is stage III. 7. Agree to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months. 8. Enough primary surgical or biopsy tissues for examination. 9. Enough peripheral blood samples for examination. 10. Agree to sign informed consent to participate in this project. Baseline population (stage Ⅳ colorectal cancer) inclusion criteria: 1. Aged 18-75. 2. Histopathological diagnosed colonic or rectal adenocarcinoma of stage IV. 3. Not yet received antineoplastic therapy. 4. Baseline imaging evaluation shows at least one measurable focus. 5. Sufficient primary surgical or biopsy tissues and metastatic tissues of at least one organ for examination. 6. Enough peripheral blood samples for examination. 7. Expected survival time ≥ 3 months. 8. 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. 9. Agree to sign informed consent to participate in this project. Metastasis colorectal cancer cohort study inclusion criteria: 1. Aged 18-75. 2. Physical condition (ECOG) score ≤ 1. 3. Colorectal adenocarcinoma was confirmed by histopathology. 4. No family history of hereditary tumor. 5. Accept standard radical resection of colorectal cancer, R0 resection, number of lymph node dissection ≥ 12. 6. Preoperative clinical stage is stage III and the postoperative pathological stage was confirmed as stage III. 7. Agreed to receive standard fluorouracil ±oxaliplatin adjuvant chemotherapy for 3 to 6 months. 8. Enough primary surgical or biopsy tissues for examination. 9. Enough peripheral blood samples for examination. 10. Agree to sign informed consent to participate in this project.
Exclusion criteria
* Baseline population (stage III colorectal cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence or metastasis provened by imageologic diagnosis (PFS) | May 31, 2023 | tumor metastasis or progression occurred during the enrolment period |
Countries
China
Contacts
Primary ContactSun Jing, PhD
Outcome results
None listed