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Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03577808
Recruitment Status : Unknown
Verified August 2018 by Zhen Zhang, Fudan University.
Recruitment status was:  Recruiting
First Posted : July 5, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Zhen Zhang, Fudan University

Study Description
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Brief Summary:
Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.

Condition or disease Intervention/treatment
Organoids Rectal Cancer Chemoradiation Other: Biopsy

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Arm
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.
 Other: Biopsy
Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice.
Criteria

Inclusion Criteria:

  • pathological confirmed adenocarcinoma
  • clinical stage T3-4 and/or N+
  • the distance from anal verge less than 12 cm
  • without distance metastases
  • KPS >=70
  • without previous anti-cancer therapy
  • sign the inform consent

Exclusion Criteria:

  • pregnancy or breast-feeding women
  • serious medical illness
  • baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577808


Contacts
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Contact: Lijun Shen, MD 86-2164175590 lijunshen@fudan.edu.cn
Contact: Zhen Zhang, MD 86-2164175590 zhen_zhang@fudan.edu.cn

Locations
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China
Fudan University Recruiting
Shanghai, China
Contact: Lijun Shen, MD    86-2164175590    lijunshen@fudan.edu.cn   
Contact: Zhen Zhang, MD    86-2164175590    zhen_zhang@fudan.edu.cn   
Principal Investigator: Zhen Zhang, MD         
Principal Investigator: Guoqiang Hua, PhD         
Sponsors and Collaborators
Zhen Zhang
Investigators
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Principal Investigator: Zhen Zhang, MD Fudan University
Principal Investigator: Guoqiang Hua, PhD Institute of Radiation Medicine, Fudan University
More Information
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Responsible Party: Zhen Zhang, Professor Zhang, Fudan University
ClinicalTrials.gov Identifier: NCT03577808    
Other Study ID Numbers: FDRT-R008
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases