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Status unknownNCT03453307Updated Mar 5, 2018

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

An observational study in NSCLC, sponsored by K2 Oncology, Inc.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by K2 Oncology, Inc. · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • NSCLC

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Keywords

  • Tumor Organoids
  • Drug Sensitivity
  • NSCLC
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group-1

    NSCLC patients receiving chemotherapy or target therapy treatment.

05

What researchers measure

Primary outcomes

  1. Correlation of ex vivo sensitivity test on patient derived organoid models

    The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment.

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • People's Hospital of Hebei Province
    Shijiazhuang, Hebei 050051, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03453307
Lead sponsor
K2 Oncology, Inc.
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Jan 30, 2018
Primary completion
Jul 30, 2020 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Mar 5, 2018

Study contacts

Zhijian Sun, Dr.
Contact
zjsun@k2oncology.com
(86) 18201013329
Chenggang Zhu, Dr.
Contact
cgzhu@k2oncology.com
(86) 18621958197
Zhijian Sun, Dr.
principal investigator · K2 Oncology, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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