Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Immune System Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Hypersensitivity

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Tyrosine

Young Joo Min, M.D.

Lung cancer is the leading cause of cancer-related death worldwide and is well known to remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80% of all the cases of lung cancer.

Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of NSCLC patients.

Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR TKI sensitivity.

Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered. G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.

However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR mutations are also observed. These rare mutations have not been fully described and data on their correlation with response to EGFR-TKIs are still unclear.

Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients, which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon 20, have some possibility of EGFR TKI sensitivity.

Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during the short period.

Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC

Efficacy of EGFR Tyrosine Kinase Inhibitors (EGFR TKIs) in Patients With EGFR-mutated Non-small Cell Lung Cancer Except Both Exon 19 Deletion and Exon 21 L859R: A Retrospective Analysis

AstraZeneca

Ulsan University Hospital

Professor

NSCLC patients receiving chemotherapy or target therapy treatment.

Zhijian Sun, Dr.

Chenggang Zhu, Dr.

Lijun Liu

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.

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.

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.

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

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

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

K2 Oncology, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

no intervention

Dongling Zou, M.D.

The tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.This is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(OC) patients.

Tissue will be received from operative specimens( primary ovarian carcinoma) at time of primary cytoreductive surgery.Ovarian cancer(OC) organoids will be then cultured. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and immunohistochemistry (TP53, PAX8 etc). After then, the patient-derived organoids cultured from OC will be compared the sensitivity to standard regimens (chemotherapies and targeted agents) recommendated by NCCN guidlines versus patients treated in clinical practice.

Ovarian cancer tissues were cut into 1-3 mm3 pieces. Two random pieces were snap frozen and stored at -80℃ for DNA isolation, two random pieces were fixed in formalin for histopathological analysis, and the remainder was processed for organoids.

The Culture of Ovarian Cancer Organoids and Drug Screening

Drug Screening of Patient-derived Organoids From Ovarian Cancer Culture to Personalized Therapy,an Exploratory Research

Chongqing University Cancer Hospital

Director of Gynecologic Oncology Department

Cholangiocarcinoma

Adenocarcinoma

Bile Duct Cancer

The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the exploration cohort.

No interventions.

Honghua Zhang, PhD

Chao Liu, PhD

This is a single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the consistency and accuracy of patient-derived organoid model of cholangiocarcinoma to predict the clinical chemotherapeutic efficacy, as well as the possibility of guiding the adjuvant chemotherapy.

The chemotherapeutic efficacy is heterogeneous among cholangiocarcinoma patients after radical resection, and an accurate and relatively convenient model evaluating the chemotherapeutic efficacy is still lacking. This study aims to prospectively evaluate the consistency of drug sensitivity between patient-derived organoid model and the actual clinical chemotherapeutic efficacy in cholangiocarcinoma patients, assisting in guiding precision medicine and making therapeutic decisions.

Drug sensitivity tests include single drug and drug combination. The organoids that are successfully cultured will be kept in liquid nitrogen for a specific time.

Resected tumor samples will be used to culture organoids for drug sensitivity testing. And the organoids that are successfully cultured will be kept in liquid nitrogen for a specific time.

Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients

Clinical Study on the Drug Sensitivity Consistency of Patient-Derived Organoid Model and Actual Therapeutic Efficacies in Cholangiocarcinoma Patients Receiving Adjuvant Chemotherapy After Radical Resection

The cholangiocarcinoma patients after radical resection are regularly followed-up for the progression-free survival status.

The drug sensitivity is tested on patient-derived tumor organoids, which is evaluated using Promega CellTiter-Glo 3D Cell Viability Assay to calculate the relative IC50, and is compared with the actual chemotherapeutic efficacy of cholangiocarcinoma patients.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Fei Liu, MD

Jing Xue, MD

Liangrong Shi

Liangrong Shi, MD

This study is aimed to establish an organoid-on-chips technological system based on biopsy samples and evaluate its efficacy in predicting the response to mFOLFOX6 infusion in patients with hepatocellular carcinoma (HCC).

This is a two-stage, multi-center real-world observational study. In stage 1, we aim to establish the technical system of organoid-on-chips culture system based on biopsy samples from patients with malignant solid tumors including breast cancer, lung cancer, liver cancer, bile duct cancer and pancreatic cancer, et.al. In stage 2, we aim to evaluate the predicting efficacy of the established organoid-on-chips system in HCC patients who undergo hepatic artery infusion (HAI) with mFOLFOX6 (oxaliplatin 85mg/m\^2, d1, HAI for 2h; calcium folinate 200mg/m\^2, d1, HAI for 1h; fluorouracil 400mg/m\^2, hepatic artery injection; fluorouracil 2400mg/m\^2, HAI for 46h).

An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC

An Pancancer Study on Organoid-on-chips Technological System Based on Biopsy Samples and Its Efficacy in Predicting the Response to mFOLFOX6 Infusion in Hepatocellular Carcinoma

The number of successful cases of Organoid culture divided by the number of enrolled cases

The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response mRECIST) to mFOLFOX6 infusion in HCC

The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response mRECIST) to mFOLFOX6 infusion in intent-to-treat HCC population

The predictive role of Organoid drug sensitivity test results and the survival period of patients with HCC receiving mFOLFOX6 infusion.

Xiangya Hospital of Central South University

Sarcoma

Sarcoma, Alveolar Soft Part

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Alveolar Soft Part Sarcoma

Michael Dean, Ph.D.

Background:

Alveolar soft part sarcoma (ASPS) is a rare tumor.

ASPS is resistant to chemotherapy and radiation.

ASPS is characterized by slow growth.

Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations.

Primary Objectives:

Acquisition of blood and tissue from patients with ASPS.

Acquisition of blood from healthy controls for comparison with blood from patients with ASPS. These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046.

Eligibility:

Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease.

Design:

Patients with Alveolar Soft Part Sarcoma (ASPS) will be eligible for this study. Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure. Blood sample may be collected at initial visit and follow-up visits. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor samples and blood samples will be processed and/or stored for use in research efforts in the laboratory of Dr. David Vistica, National Cancer Institute, Frederick, MD. Additionally, blood samples will be obtained from healthy volunteers for comparison to patients with ASPS. These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046.

Background:

Alveolar soft part sarcoma (ASPS) is a rare tumor.

ASPS is resistant to chemotherapy and radiation.

ASPS is characterized by slow growth.

Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations were generated under this protocol.

Additional models are needed to represent the heterogeneity of this disease.

Primary Objectives:

Acquisition of blood and tissue from patients with ASPS.

Acquisition of blood from healthy controls for comparison with blood from patients with ASPS. These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046.

Eligibility:

Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease.

Design:

Patients with Alveolar Soft Part Sarcoma (ASPS) will be eligible for this study. Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure. Blood sample may be collected at initial visit and follow-up visits. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor samples and blood samples will be processed and/or stored for use in research efforts in the laboratory of Dr. Robert Shoemaker, National Cancer Institute, Frederick, MD. Additionally, blood samples will be obtained from healthy volunteers for comparison to patients with ASPS. These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046.

Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research

Procurement of Blood and Tissue From Patients With Primary and Metastatic Alveolar Soft Part Sarcoma and Blood From Healthy Controls for In Vitro and In Vivo Model Development

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC	NCT01775943	Lung Neoplasms		-	Ulsan University Hospital
Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients	NCT03453307	NSCLC		18 Years -	K2 Oncology, Inc.
The Culture of Ovarian Cancer Organoids and Drug Screening	NCT04768270	Ovarian Cancer	no intervention	18 Years - 70 Years	Chongqing University Cancer Hospital
Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients	NCT05634694	Cholangiocarcin...	No intervention...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC	NCT05932836	Hepatocellular ...	No intervention...	18 Years - 75 Years	Xiangya Hospital of Central South University
An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC	NCT05932836	Hepatocellular ...	No intervention...	18 Years - 75 Years	Xiangya Hospital of Central South University
Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC	NCT01775943	Lung Neoplasms		-	Ulsan University Hospital
Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research	NCT00340353	Alveolar Soft P... Sarcoma		4 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for drug sensitivity