Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.
NCT ID: NCT04906733
Last Updated: 2021-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2021-04-15
2023-12-31
Brief Summary
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Detailed Description
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Objectives
1. To assess the effective rate of cetuximab target therapy on RAS/RAF wild-type right colon cancer
2. To assess the consistency of organoid chemotherapy sensitivity and clinical chemotherapy efficacy
3. To assess the consistency of organoid cetuximab sensitivity and clinical cetuximab efficacy
The following points will be addressed:
1. The biopsy tissue of RAS/RAF wild-type metastatic right colon cancer will be collected and subject to ex vivo 3-D culture to establish patient-derived tumor organoids, which will be used for the drug sensitivity test.
2. Enrolled patients will treat with chemotherapy or chemotherapy combined target therapy. The medication regime and treatment cycle will be decided based on the clinical guideline and evidence-based medicine.
3. The patient-derived organoid-based drug sensitivity test will compare with clinical treatment data of chemotherapy or chemotherapy combined target therapy, followed by correlation analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cancer patient
RAS/RAF wild-type metastatic right colon cancer patients receiving chemotherapy or chemotherapy combined target therapy treatment.
Tumor biopsy
Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy.
Interventions
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Tumor biopsy
Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy.
Eligibility Criteria
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Inclusion Criteria
2. The primary tumor is located in the right colon, including the ileocecal area, ascending colon, liver flexure, and the right part of the transverse colon.
3. Pathologically proved primary intestinal tumor with simultaneous / metachronous metastasis
4. Molecular pathology confirmed as RAS/RAF wild type
5. Can tolerate and cooperate with the completion of chemotherapy and targeted therapy
6. Tissues can be obtained through puncture or colonoscopy for organoid culture
7. Complete clinical data, as well as efficacy evaluation data, can be obtained
Exclusion Criteria
2. The primary tumor is located in the left colon or rectum
3. Pathology results can't confirm as colon cancer
4. RAS and RAF are mutant confirmed by molecular pathology
5. Refuse to cooperate and complete the treatment, or there is a contraindication for chemotherapy or targeted therapy
6. No available metastatic lesions tissue
7. Unable to obtain complete clinical data or efficacy evaluation data
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
D1 Medical Technology (Shanghai) Co., Ltd, China
INDUSTRY
Responsible Party
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Principal Investigators
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Junjie Peng, Dr.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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D1med-ZL01
Identifier Type: -
Identifier Source: org_study_id
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