Clinical trial NCT04755907: 3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases
Official title: Validation of the Three-dimensional Bioprinted Tumor Models as a Predictive Method of the Response to Chemotherapy for Colorectal Cancer With or Without Liver Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colorectal Cancer Liver Metastasis
Keywords: colorectal cancer
colorectal cancer liver metastasis
three-dimensional bioprinting
chemotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: China-Japan Friendship Hospital
First posted: 2021-02-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically and pathologically proven colorectal cancer patients are considered as potential candidates of this study. Medical history will be thouroughly taken by clincal practicitioners. Only patients older than 18 years will be included. Those with medical hostory of other malignancies or serious diseases will be excluded. Patients who are not able to sign the informed consent independently will not be included in this study. All the patients included in this study will receive adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of CRC.

Brief summary: The therapeutic regimens of adjuvant and neoadjuvant chemotherapy for colorectal cancer (CRC) remain largely relied on clinical experience, and thus preclinical models are needed to guide individualized medicine. The investigators are going to establish 3D bioprinted CRC models and organoids from surgically resected tumor tissues of CRC patients with or without liver metastases. In vitro 3D models and organoids will be treated with the same chemotherapy drugs with the corresponding patients from whom the models are derived. The sensitivity of chemotherapy drugs will be tested in these two types of in vitro models, and the actual response to chemotherapy in patients will be evaluated. The predictive ability of 3D models for chemotherapy sensitivity in CRC patients will be compared with that of the organoids. This observational study will validate the potential value of 3D bioprinted tumor models in predicting the response to chemotherapy in CRC.


Eligibility criteria: Inclusion Criteria:

* More than 18 years old
* Diagnosed as colorectal cancer with or without liver metastases before
* Pathologically proven colorectal cancer after surgery

Exclusion Criteria:

* Medical history with other malignancies or serious diseases
* Disable to sign the informed consent independently

Primary outcomes:
measure: Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.
timeFrame: 2021.03-2021.12
Secondary outcomes:
measure: Response of the colorectal cancer patients to neoadjuvant chemotherapy.
timeFrame: 2021.03-2022.03
Other outcomes:
measure: Response of the colorectal cancer patients to adjuvant chemotherapy.
timeFrame: 2021.03-2023.12
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yilei Mao, MD PhD
role: PRINCIPAL_INVESTIGATOR
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