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Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients

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ClinicalTrials.gov Identifier: NCT03453307
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
K2 Oncology, Inc.

Brief Summary:
This clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids.

Condition or disease
NSCLC

Detailed Description:

Methods - Open label single arm observatory comparison experiment

  1. Enrolled patients (before or after surgery) were treated with chemotherapy or target therapy. The medication regime and treatment cycle were decided based on the clinical guideline and evidence-based medicine. This clinical study will not affect the treatment plan of the patients.
  2. The resection tissue or biopsy tissue of NSCLC will be collected, and subject to ex vivo 3-D culture to establish patient-derived tumor organoid models, which will be used for drug sensitivity test.
  3. The patient-derived organoid-based drug sensitivity test will be compared with clinical treatment data of chemotherapy or target therapy, followed by correlation analysis.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Correlation Study of the Drug Sensitivity Between Ex Vivo Model of Non-Small Cell Lung Cancer (NSCLC) Patient-Derived Organoids and Clinical Response in NSCLC Patients
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort
Group-1
NSCLC patients receiving chemotherapy or target therapy treatment.



Primary Outcome Measures :
  1. Correlation of ex vivo sensitivity test on patient derived organoid models [ Time Frame: 12 months ]
    The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment.


Biospecimen Retention:   Samples Without DNA
Tumor samples from surgical resection of enrolled NSCLC patients are to be collected, and subject to organoid isolation followed by ex vivo drug sensitivity test.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Metastatic NSCLC patients with axillary and other region lymph nodes metastasis. The biopsy and/or surgery tissue samples of metastatic and/or primitive tumor are accessible.
Criteria

Inclusion Criteria:

  • Aged 18 years old or more;
  • Late stage NSCLC patients, with tumor invasion confirmed by histopathology analysis. Metastasis of axillary lymph nodes and other region lymph nodes are confirmed with histopathologic or cytopathologic analysis;
  • Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumor;
  • No clinical evidence of other malignancy, unstable complication or uncontrolled infection;
  • Life expectancy > 12 months.
  • Informed and signed consent by the patient.

Exclusion Criteria:

  • Not accessible to biopsy and/or surgery sample;
  • Patient already enrolled in another clinical trial with another first line of chemotherapy;
  • Unmeasurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria;
  • Women who are pregnant, plan to become pregnant or are lactating during the study;
  • Elevation of carcinoembryonic antigen (CEA) observed without distal metastases found;
  • Have some kind of contraindications for chemotherapy and targeted therapy: cardiovascular and cerebrovascular diseases; liver and kidney function deficiency; hematological system diseases; clinician consider the patients are not suitable for chemotherapies or target therapies;
  • Have other malignant tumor previously;
  • Have surgical contraindications: anesthesia taboo; surgery unresectable extensive lesions;
  • State of health can't finish the study;
  • Patient already enrolled in another clinical trial with another anti-cancer therapy or plan to participate in other clinical study.
  • No self-determination or refuse to participant.
  • With unlisted exclusion criteria but are considered not suitable for the clinical study by researchers.

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): NCT03453307


Contacts
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Contact: Zhijian Sun, Dr. (86) 18201013329 zjsun@k2oncology.com
Contact: Chenggang Zhu, Dr. (86) 18621958197 cgzhu@k2oncology.com

Locations
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China, Hebei
People's Hospital of Hebei Province Recruiting
Shijiazhuang, Hebei, China, 050051
Contact: Lijun Liu    18903391188    13833131067@163.com   
Sponsors and Collaborators
K2 Oncology, Inc.
Investigators
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Principal Investigator: Zhijian Sun, Dr. K2 Oncology, Inc.

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Responsible Party: K2 Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03453307     History of Changes
Other Study ID Numbers: K2OLC-001
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by K2 Oncology, Inc.:
Tumor Organoids
Drug Sensitivity
NSCLC

Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases