3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases
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
1 other identifier
observational
120
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 19, 2022
July 1, 2022
1.8 years
February 13, 2021
July 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.
The investigators will establish and culture 3D colorectal cancer models and organoids. The 3D models and organoids will be treated with the same chemotherapy drugs as the corresponding patients. The viability of the 3D tumor models and organoids will be observed after treatment and the IC50 of each drug will be calculated. The correlation of 3D model/organoid sensitivity and the patient response will be analyzed.
2021.03-2021.12
Secondary Outcomes (1)
Response of the colorectal cancer patients to neoadjuvant chemotherapy.
2021.03-2022.03
Other Outcomes (1)
Response of the colorectal cancer patients to adjuvant chemotherapy.
2021.03-2023.12
Study Arms (3)
Group A
colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery
Group B
colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery
Group C
colorectal cancer patients with liver metastases
Interventions
Surgical resection will be performed for locoregional lesions or liver metastases.
Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.
Regimens of neoadjuvant chemotherapy are directed by clinical guidance and experience.
Eligibility Criteria
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.
You may qualify if:
- More than 18 years old
- Diagnosed as colorectal cancer with or without liver metastases before
- Pathologically proven colorectal cancer after surgery
You may not qualify if:
- Medical history with other malignancies or serious diseases
- Disable to sign the informed consent independently
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100143, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (6)
Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.
PMID: 30704229BACKGROUNDBrancato V, Oliveira JM, Correlo VM, Reis RL, Kundu SC. Could 3D models of cancer enhance drug screening? Biomaterials. 2020 Feb;232:119744. doi: 10.1016/j.biomaterials.2019.119744. Epub 2019 Dec 26.
PMID: 31918229BACKGROUNDBruun J, Kryeziu K, Eide PW, Moosavi SH, Eilertsen IA, Langerud J, Rosok B, Totland MZ, Brunsell TH, Pellinen T, Saarela J, Bergsland CH, Palmer HG, Brudvik KW, Guren T, Dienstmann R, Guren MG, Nesbakken A, Bjornbeth BA, Sveen A, Lothe RA. Patient-Derived Organoids from Multiple Colorectal Cancer Liver Metastases Reveal Moderate Intra-patient Pharmacotranscriptomic Heterogeneity. Clin Cancer Res. 2020 Aug 1;26(15):4107-4119. doi: 10.1158/1078-0432.CCR-19-3637. Epub 2020 Apr 16.
PMID: 32299813BACKGROUNDYao Y, Xu X, Yang L, Zhu J, Wan J, Shen L, Xia F, Fu G, Deng Y, Pan M, Guo Q, Gao X, Li Y, Rao X, Zhou Y, Liang L, Wang Y, Zhang J, Zhang H, Li G, Zhang L, Peng J, Cai S, Hu C, Gao J, Clevers H, Zhang Z, Hua G. Patient-Derived Organoids Predict Chemoradiation Responses of Locally Advanced Rectal Cancer. Cell Stem Cell. 2020 Jan 2;26(1):17-26.e6. doi: 10.1016/j.stem.2019.10.010. Epub 2019 Nov 21.
PMID: 31761724BACKGROUNDXie F, Sun L, Pang Y, Xu G, Jin B, Xu H, Lu X, Xu Y, Du S, Wang Y, Feng S, Sang X, Zhong S, Wang X, Sun W, Zhao H, Zhang H, Yang H, Huang P, Mao Y. Three-dimensional bio-printing of primary human hepatocellular carcinoma for personalized medicine. Biomaterials. 2021 Jan;265:120416. doi: 10.1016/j.biomaterials.2020.120416. Epub 2020 Sep 22.
PMID: 33007612BACKGROUNDSun L, Yang H, Wang Y, Zhang X, Jin B, Xie F, Jin Y, Pang Y, Zhao H, Lu X, Sang X, Zhang H, Lin F, Sun W, Huang P, Mao Y. Application of a 3D Bioprinted Hepatocellular Carcinoma Cell Model in Antitumor Drug Research. Front Oncol. 2020 Jun 3;10:878. doi: 10.3389/fonc.2020.00878. eCollection 2020.
PMID: 32582546BACKGROUND
Biospecimen
resected tumor tissue from surgery
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yilei Mao, MD PhD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2021
First Posted
February 16, 2021
Study Start
March 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
July 19, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The IPD data will available after the study is completed.
- Access Criteria
- Data can be accessed via e-mail with reasonable requests.
Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.