Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Coagulants

Pharmaceutical Solutions

Iodine

Lugol's solution

Cadexomer iodine

Hemostatics

Each study participant will undergo esophageal sponge sampling using the 'EsophaCap' sponge device. Group 1 will include a safety-phase, which will consist of a lead-in cohort of 8 patients with ESCC. Subsequent recruitment of ESCC Cases (Group 1) will not commence until the Data Safety Monitoring Board (DSMB) has deemed the safety lead-in data appropriate for continuation. Following collection of esophageal cells, samples will be assessed using the EsoCAN assay. Study participant evaluations will be taken at baseline, immediately after undergoing esophageal sponge sampling, and 7 days following administration of the 'EsophaCap' device.

Each study participant will undergo (1) Esophagogastroduodenoscopy (EGD) with chromoendoscopic screening and possible biopsy, and (2) esophageal sponge sampling using the 'EsophaCap' sponge device. Pathology from chromoendoscopic screening will be used to categorize non-ESCC study participants as esophageal squamous dysplasia (ESD) cases and controls. Following collection of esophageal cells, samples will be assessed using the EsoCAN assay. Study participant evaluations will be taken at baseline, immediately after undergoing esophageal sponge sampling, and 7 days following administration of the 'EsophaCap' device.

Non-invasive strategy to sample esophageal tissue

EsophaCap Sponge

Lugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus

Chromoendoscopy

EsoCAN assay

Geoffrey Buckle, MD, MPH

Yona Ringo

Katherine Steitz, MD, MPH

In the current protocol, we propose a study to evaluate a novel, combined esophageal sponge-methylation biomarker strategy for the early detection of esophageal squamous cell carcinoma (ESCC) as well as its precursor, esophageal squamous dysplasia (ESD). This strategy leverages the 'EsophaCap', a swallowable, retrievable sponge, with subsequent evaluation of the sample using a novel molecular biomarker assay. This biomarker assay evaluates methylation levels in select genes, which have been shown to differ significantly between ESCC cases and controls in pilot studies. Detection of methylation markers highly associated with ESCC could help identify patients with concurrent ESCC or at high risk of imminently developing this condition. If successful, this strategy could result in a paradigm shift for esophageal cancer control strategies in Tanzania and other high-incidence ESCC regions.

PRIMARY OBJECTIVE:

I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with use of the EsoCAN assay, a novel molecular biomarker assay, among patients with histologically-confirmed ESCC cases and controls.

SECONDARY OBJECTIVES:

I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with use of the the EsoCAN assay, among patients with histologically-confirmed ESD and controls.

II. To evaluate the safety and feasibility of 'EsophaCap' a swallowable and retrievable sponge, as a non-invasive strategy for screening and early detection of ESCC and its precursor, ESD, in Tanzania.

EXPLORATORY OBJECTIVES:

I. Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESCC cases and controls.

II. Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESD cases and controls.

III. To examine methylation levels in new and previously identified genes among patients recruited as suspected ESCC cases who are found to have an alternative diagnosis, with the goal of optimizing the EsoCAN Assay.

OUTLINE:

Each participant will undergo esophageal sponge sampling suing the 'EsophaCap' sponge device. Participants will be on study for up to 38 days.

Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma

The proportion of participants with a positive EsoCAN assay result, among patients with histologically-confirmed Esophageal Squamous Cell Carcinoma (ESCC). The following equation will be used as a cut point for ESCC using the EsoCAN assay \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of greater than -2.327 is classified as positive.

The proportion of participants with a negative EsoCAN assay result for will be reported, among study participants who are classified as controls. The following equation will be used as a cut point for ESCC using the EsoCAN assay \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of less than -2.327 is classified as negative.

The proportion of participants with both a positive EsoCAN assay result, among patients with histologically-confirmed Esophageal Squamous Dysplasia (ESD). The following equation will be used as a cut point for ESD: \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of greater than -2.327 is classified as positive.

The proportion of participants with a negative EsoCAN assay result will be reported. The following equation will be used as a cut point for ESD: \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of less than -2.327 is classified as negative.

The success of swallowing the esophageal sponge device will be determined by the clinical team overseeing the EsophaCap' administration and categorized as a dichotomous response of Yes (successful) or No (not successful).

Adverse events for the lead in cohort with histologically confirmed or suspected ESCC based upon pre-specified clinical criteria will be reported and graded and classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Participants will be asked to rate their satisfaction with their experience with the EsophaCap sponge procedure after the procedure is complete by selecting a score on a scale with corresponding facial images with scores ranging between 0='Best Experience' (large smile on facial expression) to 10='Worst experience' (crying and frowning facial expression).

National Cancer Institute (NCI)

Johns Hopkins University

Muhimbili University of Health and Allied Sciences

CapNostics, LLC

University of California, San Francisco

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

biomarker detection

Shirong Zhang, Ph.D

Shirong Zhang, Dr.

This study aims to dynamically monitor the expression profile status of peripheral blood mononuclear cells (PBMC) and the changes in circulating tumor DNA (ctDNA) levels in patients with stage III locally advanced unresectable non-small-cell lung cancer(NSCLC) after concurrent chemoradiotherapy or sequential chemoradiotherapy, and to explore biomarkers related to the immune microenvironment and the optimal time point for immunotherapy after chemoradiotherapy.

Biomarkers of Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer

Dynamic Biomarkers of Immune Microenvironment for Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer

According to the biomarker detection before and after chemoradiotherapy to identify biomarkers related to the immune microenvironment, including the expression levels of NK cells, T cells, B cells and other immune cells reflected by PBMC, as well as the expression levels of ctDNA

Changes in the expression levels of ctDNA and PBMC immune cells before and after chemoradiotherapy to find the optimal time point for immunotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma	NCT05028725	Esophageal Squa... Esophageal Squa...	EsophaCap Spong... Chromoendoscopy EsoCAN assay	18 Years -	University of California, San Francisco
Biomarkers of Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer	NCT04749407	Non-small Cell ...	biomarker detec...	18 Years - 70 Years	First People's Hospital of Hangzhou
Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma	NCT05028725	Esophageal Squa... Esophageal Squa...	EsophaCap Spong... Chromoendoscopy EsoCAN assay	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for biomarker detection