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| Name | Class |
|---|---|
| Fudan University | OTHER |
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Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy. The investigators will establish organoids from the pre-treatment biopsies. Organoids will be exposed to the chemotherapy drugs or chemotherapy drugs combined with cetuximab used for each patient. The sensitivity of chemotherapy drugs or combined cetuximab will be tested in the organoids model. Chemotherapy strategies including 5-fluorouracil only, irinotecan only, oxaliplatin only, FOLFOX, and FOLFIRI. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) model of colon cancer to predict the clinical efficacy of combined treatment of cetuximab, which to formulate the best therapy regimen for each given patient.
Investigators hypothesize that the cetuximab sensitivity test results on patient-derived organoids can be used to predict the treatment selection of patients with RAS/RAF wild-type metastatic right colon cancer.
Objectives
The following points will be addressed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patient | RAS/RAF wild-type metastatic right colon cancer patients receiving chemotherapy or chemotherapy combined target therapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor biopsy | Procedure | Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of ex vivo sensitivity test on patient-derived organoid models with clinical outcomes | The drug sensitivity tests on patient-derived tumor organoids will compare with the clinical response of the chemo- or targeted therapy treatment. The correlation of organoids sensitivity and patient response will be evaluated. | 2021.05-2023.05 |
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Inclusion Criteria:
Exclusion Criteria:
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The Department of Colorectal Surgery in Fudan University Cancer Hospital is one of the largest colorectal cancer diagnosis and treatment centers in China. In 2019, more than 1,000 cases of recurrent and metastatic colorectal cancer were diagnosed and treated. It is sufficient to obtain samples for this study from patients diagnosed and treated in this department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanqing Lin, Dr. | Contact | +8615921348040 | linhq@d1med.com | |
| Chunyan Cheng, Dr. | Contact | +8613916290275 | chengcy@d1med.com |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Peng, Dr. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2021 | Jun 1, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Tumor samples of biopsy tissue from enrolled RAS/RAF wild-type metastatic right colon cancer patients are to be collected and subject to organoid isolation followed by the ex vivo drug sensitivity test.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |