Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Adenocarcinoma

Gastroesophageal Reflux

Barrett Esophagus

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Precancerous Conditions

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

400 eligible primary care providers (PCPs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible PCPs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for providers to complete a paper survey at PCP clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.

100 eligible gastroenterologists (GIs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible GIs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for GIs to complete a paper survey at provider clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.

500 eligible patients will be recruited across the 7 participating sites to complete a survey. The survey will be distributed to eligible patients at the time of a clinic appointment, via telephone, or via a REDCap internet survey that will allow for 2 additional electronic phone call reminders and 1 email reminder.

To assess PCP demographics, attitudes, and perceived barriers to BE screening, we have developed a PCP survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess PCP knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 PCPs.

Primary Care Provider Survey

To assess GI demographics, attitudes, and perceived barriers to BE screening, we have developed a GI survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess GI knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 GIs.

Gastroenterologist Survey

To assess patient knowledge, attitudes, and barriers to completion of BE screening, we will use a theoretical model of patient behavior on the Health Behavior Framework to guide selection of relevant variables for survey development including 4 domains: knowledge about BE and EAC, potential barriers to BE screening completion, patient attitudes and demographic information. Prior to distribution, the survey will be refined and pretested among a sample of 10 patients with each participant completing a cognitive interview prior to distribution.

Patient Survey

Sachin Wani, MD

The goal of this study is to optimize Barrett's Esophagus (BE) screening to reduce the incidence, morbidity, and mortality of Esophageal Adenocarcinoma (EAC).

The initial step to achieve this goal is to study shortcomings of the current BE screening referral processes in the United States. These shortcomings will be identified through completion of two synergistic aims that assess:, (1) provider knowledge, attitudes, and barriers to BE screening referral and (2) patient knowledge, attitudes, and barriers to completion of BE screening. The central hypothesis is that there are patient- and provider-level factors that can be modified to improve BE screening adherence. This hypothesis was formulated based on strong preliminary data demonstrating significant single-mindedness among gastroenterologists regarding BE screening criteria.

Survey Study on Barrett's Esophagus Screening

Study of Compliance, Practice Patterns, and Barriers REgarding Established National Screening Programs for Barrett's Esophagus: SCREEN-BE

This investigator will conduct a survey study among primary care providers and gastroenterologists at 7 large health systems in the U.S.-including 4 tertiary care referral centers and 3 safety-net health systems. Based on constructs from Social Cognitive Theory and Theory of Reasoned Action, the survey will assess provider knowledge, attitudes, and barriers to BE screening among at-risk individuals.

This investigator will conduct a survey study among patients at 7 large health systems in the U.S. Based on constructs from the Health Behavior Framework, the survey will assess patient knowledge, attitudes, and barriers to BE screening. To accomplish these study aims, this investigator has assembled a strong and diverse team with complementary areas of expertise in Barrett's esophagus, and survey research.

American College of Gastroenterology

University of Colorado, Denver

The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.

Captivator™ EMR

Jacques Bergman, MD

To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.

The Captivator EMR Registry

An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus

Successful resection is assessed during the EMR procedure

The number of resection per procedure is assessed during the EMR Procedure

Total procedure time is assessed during the EMR procedure

Study subjects will have follow-up visits after the EMR procedure during which the occurrence of adverse events related to the Captivator EMR procedure or device will be assessed. These visits will occur at the following time points:

* Immediately following the EMR procedure (Post procedure evaluation)
* 48 hour telephone call
* 30 day telephone call
* Unscheduled clinic visits will be performed in-between protocol required follow-up, as necessary.

Once the 30 day phone call is complete, the subject will have completed the study.

Accessory device use is assessed during the EMR procedure

Endoscopic management of complications is assessed during the EMR procedure

Accessory devices used to complete resection is assessed during the EMR procedure

Histopathology of resection specimens is performed per standard of practice at each participating study center. Results are expected within approximately 7 days of the EMR procedure.

Boston Scientific Corporation

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

* IV-administration of EMI-137: all patients will receive 0.13 mg/kg of the fluorescent tracer EMI-137 intravenously.
* Molecular Fluorescence Endoscopy: approximately 2,5 hours after tracer administration, Molecular Fluorescence Endoscopy will be performed with additional measurements of fluorescence signals.

Intravenous administration of 0.13 mg/kg of the fluorescent tracer EMI-137 approximately 2.5 hours prior to the endoscopy procedure.

IV-administation of EMI-137

A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working-channel of the standard clinical endoscope. Fluorescence imaging will be performed prior to and post the endoscopic resection, during the same endoscopy procedure.

Molecular Fluorescence Endoscopy platform

W.B. Nagengast, MD, PhD, PharmD

G.M. van Dam, MD, PhD

To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker c-Met is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging.

Edinburgh Molecular Imaging Ltd (EMI) has developed a fluorescent tracer specifically targeting c-Met by labeling a small peptide to a fluorescent fluorophore: 'EMI-137'. The investigators hypothesize that when EMI-137 is administered intravenously, it accumulates in c-Met expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling (early) cancer visualization using a newly developed fluorescent fiber-bundle. This hypothesis will be tested in the current pilot intervention study.

Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions

Molecular Fluorescence Endoscopy for the Detection of (Pre)Malignant Lesions in Barrett's Esophagus Using a Fluorescent Tracer 'EMI-137' Targeting c-Met: a Single-center Feasibility and Safety Study

Calculation of the in vivo tumor-to-background ratio (\> 1.5) based on fluorescence intensities in (pre)malignant lesions compared to surrounding healthy esophageal tissue.

University Medical Center Groningen

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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

Stomach Diseases

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

Pembrolizumab

Carboplatin

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

sigvotatug vedotin + pembrolizumab +/- (carboplatin)

Administered into the vein (IV; intravenously)

sigvotatug vedotin

200mg every 3 weeks or 400mg every 6 weeks, given by IV

pembrolizumab

cisplatin

AUC 5 mg/mL per min every 3 weeks, given by IV

carboplatin

Seagen Trial Information Support

Ingrid Acker

Cesar Perez Batista, MD

Alisa Posner

Bruno Bockorny, MD

Illya Dixon

Kartik Sehgal

Edwin C Kingsley

Megan Boland

Afshin Dowlati

Providence Cancer Institute CT.Gov Contact

Rachel E Sanborn

Staci Vogel

Steven Powell

Rabia Khan

Sarina A Piha-Paul

Isabel Jimenez

Amita Patnaik

Yiqun (Lydia) Xue

Joseph Z Ye

Antoine Hollebecque

Tatiana Carolina Hernandez Guerrero

Elena Garralda Cabanas

Alvaro Rodriguez Lescure

Jesus Corral

Federico Longo

Emiliano Calvo

Fernando Rivera Herrero

Solange Peters

Elisa Fontana

Juanita Lopez

Medical Monitor

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

* Part A of the study will find out how much sigvotatug vedotin should be given to participants.
* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.
* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.
* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.
* In Parts C and D, participants will receive sigvotatug vedotin with either:

  * Pembrolizumab or,
  * Pembrolizumab and carboplatin, or
  * Pembrolizumab and cisplatin.

A Study of SGN-B6A in Advanced Solid Tumors

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to RECIST v1.1.

The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause

The time from the start of any study treatment to the first documentation of PD, or death due to any cause

The time from the start of any study treatment to the date of death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Survey Study on Barrett's Esophagus Screening	NCT04408105	Gastroesophagea... Barrett's Esoph... Esophagus Adeno...	Primary Care Pr... Gastroenterolog... Patient Survey	18 Years - 99 Years	University of Colorado, Denver
The Captivator EMR Registry	NCT02482701	Barrett's Esoph...	Captivator™ EMR	18 Years - 80 Years	Boston Scientific Corporation
Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions	NCT03205501	Barrett Esophag... Esophageal Canc... Dysplasia in Ba...	IV-administatio... Molecular Fluor...	18 Years -	University Medical Center Groningen
Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions	NCT03205501	Barrett Esophag... Esophageal Canc... Dysplasia in Ba...	IV-administatio... Molecular Fluor...	18 Years -	University Medical Center Groningen
The Captivator EMR Registry	NCT02482701	Barrett's Esoph...	Captivator™ EMR	18 Years - 80 Years	Boston Scientific Corporation
Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions	NCT03205501	Barrett Esophag... Esophageal Canc... Dysplasia in Ba...	IV-administatio... Molecular Fluor...	18 Years -	University Medical Center Groningen
A Study of SGN-B6A in Advanced Solid Tumors	NCT04389632	Carcinoma, Non-... Squamous Cell C... HER2 Negative B... Esophageal Squa... Esophageal Aden... Gastroesophagea... Ovarian Neoplas... Cutaneous Squam... Exocrine Pancre... Urinary Bladder... Uterine Cervica... Stomach Neoplas...	sigvotatug vedo... pembrolizumab cisplatin carboplatin	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for eac

Every month we try and update this database with for eac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eac

Every month we try and update this database with for eac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.