Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT03577808|
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment|
|Organoids Rectal Cancer Chemoradiation||Other: Biopsy|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer|
|Actual Study Start Date :||August 17, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice. Organoids bio-bank of pre-treatment tumor biopsies will be established and exposed to irradiation and the same chemotherapy drugs as the corresponding patient.
Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.
- Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient. [ Time Frame: 2018.08-2020.11 ]The investigators will culture rectal cancer organoids and treat with irradiation and the same chemotherapy drugs as the corresponding patient. The number and size of alive organoids will be observed after treatment. The correlation of organoids sensitivity and patient response will be evaluated.
- Response of the rectal cancer patients to neoadjuvant chemoradiation. [ Time Frame: 2018.08-2020.11 ]The investigators will use pathological tumor regression grade (TRG) to evaluate chemoradiation response of locally advanced rectal cancer patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577808
|Contact: Lijun Shen, MDfirstname.lastname@example.org|
|Contact: Zhen Zhang, MDemail@example.com|
|Contact: Lijun Shen, MD 86-2164175590 firstname.lastname@example.org|
|Contact: Zhen Zhang, MD 86-2164175590 email@example.com|
|Principal Investigator: Zhen Zhang, MD|
|Principal Investigator: Guoqiang Hua, PhD|
|Principal Investigator:||Zhen Zhang, MD||Fudan University|
|Principal Investigator:||Guoqiang Hua, PhD||Institute of Radiation Medicine, Fudan University|