Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Immune Checkpoint Inhibitors

Immunomodulating Agents

Liver Extracts

Subjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria:

1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease
3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study.
4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.

Subjects must be clinically able, at investigator discretion, to undergo additional core needle or forceps biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.

Core Needle or Forceps Biopsy

Catarina Costa

Saima Chaabane

Fereidoun Abtin, MD

Ingrid Halvorson

Heather Chalfin, MD

Laura Parisi

Richard Zuniga, MD

April Bell

Paras Patel, MD

Lorie A Fares

Andrea G Mosko

Alan Gowan, DO

Fred Hausheer, MD, FACP

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.

Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.

Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies.

In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for ICIs like PDL1, MSI, and TMB.

Fresh tissue sampling using core needle or forceps biopsy.

Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)

The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.

The AUC of Cybrid Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.

Elephas

Forceps biopsy

Endobronchial biopsy with the cryobiopsy probe

Cryobiopsy

Maik Haentschel, MD

Juergen Hetzel, MD

Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients.

Objectives

Primary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

Secondary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between

* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection)

To assess differences in side effects e.g. periinterventional bleeding

Explorative Objective:

To explore tumor mutational burden with regard to

* solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
* cytologic material by (EBUS-guided) TBNA
* liquid biopsy

Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.

Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

A Prospective, Randomized, Single Blinded Multicentre Trial to Evaluate Molecular Genetic Characterisation of Primary Diagnosed or Relapsed Non Small Cell Lung Cancer by Single or Combination of Diagnostic Procedures

to explore tumor mutational burden with regard to

* Solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
* Cytologic material by (EBUS-guided) TBNA
* Liquid biopsy

assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

assessment of differences in detection rate of molecular genetic alterations in NSCLC between

* different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4)
* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding

assessment of differences in the quantity of total mutational burden between

* different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4)
* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding

AstraZeneca

University Hospital Tuebingen

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

In this group, an endoscopist takes a forceps biopsy at depressed mucosa or large nodular area of large colorectal tumors after meticulous surface evaluation.

In this group, an endoscopist takes a forceps biopsy at the most convenient area of large colorectal tumors.

Forceps biopsy is taken after surface evaluation of the large colorectal tumors.

Targeted group

Eun Soo Kim, MD, PhD

This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.

Targeted Forceps Biopsy for Colorectal Tumors

Concordance Rate of Pathology Between Targeted Forceps Biopsy and Resected Specimen for Large Colorectal Tumors

The pathologic diagnosis of forceps biopsy is compared with the pathologic diagnosis of resected specimen of the colorectal tumor.

Kyungpook National University Hospital

Professor

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Melanoma

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Melanoma, Cutaneous Malignant

Endometrial Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Squamous Cell

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Head and Neck Neoplasms

Transitional Cell Carcinoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

Cola

Subjects suspected or diagnosed with Stage III or IV:

* Bladder: Urothelial Carcinoma (UC)
* Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)

Subjects suspected or diagnosed with Stage IV/metastatic:

* Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC)
* Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers
* Lung: Non-small cell lung cancer (NSCLC)
* Skin: Cutaneous Melanoma, excluding Uveal Melanoma
* Uterus: endometrial cancer

Subjects suspected or diagnosed with:

* Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy.
* Any metastatic solid tumor that the clinician plans to treat with ICI therapy.

Rae Richards

Juan Morales

Geetha Varma, MD

Joseph Dunn

Mark Socinski, MD

Irene Ball

Kelley Kozma, MS, DO

Jennifer Burgess

Matthew Anderson, MD, PhD

Danial Malik

Robert Martin, MD, PhD

Diane Russomanno

John Gibbs, MD

John Gaeddert

Edwin Yau, MD, PhD

Markeela Lipscomb

Desma Jones

Nima Kokabi, MD

Sara John

Giuseppe Toia, MD, MS

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform across a basket of solid tumors, using in-vivo RECIST 1.1 as the reference method.

Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called checkpoint inhibitors (CPIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.

Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on CPIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to CPIs and other immunotherapies.

In this observational clinical basket trial, participants will be recruited and their actual clinical response (using RECIST 1.1) to CPIs across five solid tumors (lung, head/neck, bladder, kidney, and skin) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for CPIs like PDL1, MSI, and TMB.

Fresh tissue sample using core needle biopsy or forceps biopsy.

Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-02)

Hoosier Cancer Research Network

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas
Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC	NCT03971175	Carcinoma, Non-... Pathology, Mole...	Forceps biopsy Cryobiopsy	18 Years -	University Hospital Tuebingen
Targeted Forceps Biopsy for Colorectal Tumors	NCT03604237	Colorectal Neop...	Targeted group	19 Years - 85 Years	Kyungpook National University Hospital
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas
Targeted Forceps Biopsy for Colorectal Tumors	NCT03604237	Colorectal Neop...	Targeted group	19 Years - 85 Years	Kyungpook National University Hospital
Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05520099	Colorectal Canc... Head and Neck S... Non Small Cell ... Cutaneous Melan... Endometrial Can... Urothelial Carc... Clear Cell Rena...	Core Needle or ...	18 Years -	Elephas
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas

Spots Global Cancer Trial Database for forceps biopsy