Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Adenocarcinoma

Barrett Esophagus

Precancerous Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

questionnaire administration

comparison of screening methods

diagnostic endoscopic procedure

esophagogastroduodenoscopy

tethered capsule endoscopy

Jason A. Dominitz, MD

RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of the esophagus, stomach, and duodenum in screening for Barrett esophagus.

PURPOSE: This phase I/II trial is studying how well a tethered capsule endoscope works in screening participants for Barrett esophagus.

OBJECTIVES:

* To determine the clinical feasibility of obtaining endoscopic esophageal images using a tethered capsule endoscope (TCE). (Phase I)
* To determine the optimal weight and possibly shape for rapid patient ingestion and extraction of the TCE. (Phase I)
* To determine the optimal tether design (e.g., rigidity, distance markings, and other material properties). (Phase I)
* To determine the optimal protocol for patient ingestion and extraction of the TCE. (Phase I)
* To compare the TCE to standard sedated esophagogastroduodenoscopy for identifying suspected Barrett esophagus. (Phase II)

OUTLINE:

* Phase I: Participants swallow the tethered capsule endoscope (TCE) so that the distal end of the TCE enters the stomach. The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is reached. The image acquisition process is repeated and the participant may be asked to swallow the TCE in up to 7 different positions with 2 swallows per position (no more than 20 swallows total).
* Phase II: Participants undergo TCE as in phase I, followed by standard sedated esophagogastroduodenoscopy (EGD) by a second physician.

Images obtained via TCE and EGD are reviewed by a third physician blinded to the results of each exam.

In both phases, participants and physicians complete a questionnaire after the TCE procedure to determine the ease of the procedure. Participants are also asked for specific suggestions to improve the TCE experience. Participants enrolled in phase II also complete a questionnaire 1 week after EGD to compare the TCE procedure with the EGD.

Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope

National Cancer Institute (NCI)

US Department of Veterans Affairs

Jason A. Dominitz

Gland and Hormone Related Diseases

Symptoms and General Pathology

Stomach Neoplasms

Pancreatic Neoplasms

Polyps

Adenomatous Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Stomach Cancer

Pancreatic Cancer

Herbal and Botanical

All Drugs and Chemicals

Cola

protein analysis

proteomic profiling

biologic sample preservation procedure

laboratory biomarker analysis

medical chart review

diagnostic colonoscopy

diagnostic endoscopic surgery

diagnostic surgical procedure

endoscopic surgery

screening colonoscopy

Kristen K Ciombor, MD

Keeli B Lewis, BS

Clinical Trials Office - Veterans Affairs Medical Center - Nas

Clinical Trials Office - Vanderbilt-Ingram Cancer Center

RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and participants undergoing colonoscopy, endoscopy, or surgery.

OBJECTIVES:

* Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and volunteers undergoing colonoscopy, endoscopy, or surgery.
* Develop new screening strategies based on substances found in tissue and biofluid samples.

OUTLINE: This is a multicenter study.

Patients and healthy volunteers undergo colonoscopy, endoscopy, or surgery. Patients and healthy volunteers also undergo tissue (e.g., tumor or normal mucosa) and biofluid (e.g., blood, urine, cyst fluids or tumor cells, bile and pancreatic juices, and/or stool) sample collection. Samples are analyzed for tumor markers by proteomic methods and protein analysis. If candidate biomarkers are identified, samples are stored for future studies involving these biomarkers. Information, including demographics, personal and family history of cancer, and prior and current colonoscopy, endoscopy, or surgery results, is collected from the medical record and stored in the project database.

Patients are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.

Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients

Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

Genomic and proteomic biomarker discovery

Vanderbilt University Medical Center

Associate Professor of Medicine

Endoscopy only when patient reports symptoms

2 yearly endoscopy versus endoscopy at need

2 yearly endoscopy

endoscopic biopsy

endoscopic procedure

QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need

quality-of-life assessment

screening method

Hugh Barr

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus.

PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.

OBJECTIVES:

Primary

* To establish whether endoscopic surveillance every 2 years or endoscopy at need only is superior in terms of overall survival and, if neither is superior, whether endoscopy at need only is non-inferior to surveillance every 2 years in patients with Barrett esophagus.

Secondary

* To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared to endoscopy at need only.
* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the incidence of esophageal cancer, gastric or esophageal cancer, or all cancers.
* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the time to diagnosis of esophageal adenocarcinoma.
* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the stage of esophageal adenocarcinoma at diagnosis using TNM staging.
* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions (e.g., ablation).
* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the frequency of endoscopy.

OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis (\< 65 years vs ≥ 65 years), length of Barrett metaplasia segment including tongues (\< 2 cm vs ≥ 2 cm and ≤ 3 cm vs \> 3 cm and ≤ 8 cm vs \> 8 cm), and newly diagnosed disease (defined as the date of endoscopy confirming Barrett metaplasia was within the past 4 months) (yes vs no). Patients are randomized to 1 of 2 intervention arms.

* Arm I: Patients undergo surveillance endoscopy with quadrantic biopsies taken every 2 cm. Patients undergo endoscopy every 2 years for a total of 6 endoscopies over 10 years.
* Arm II: Patients undergo endoscopy as needed over 10 years. All patients may undergo urgent endoscopy if they develop dysphagia, unexplained weight loss of \> 7 lb, iron-deficiency anemia, recurrent vomiting, or worsening upper gastrointestinal symptoms.

All patients complete a questionnaire that includes a quality-of-life measure and questions about medication at baseline, every 2 years, and following key events (e.g., diagnosis of any cancer or high-grade dysplasia).

Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus

Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)

Gloucestershire Hospitals NHS Foundation Trust

Professor Hugh Barr

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

curcumin

high performance liquid chromatography

pharmacological study

therapeutic conventional surgery

Contact Person

William P. Steward, MD, PhD

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of curcumin may prevent or treat colorectal cancer.

PURPOSE: This phase I trial is studying the side effects of curcumin in preventing colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery.

OBJECTIVES:

Primary

* To determine levels of curcumin and its metabolites in normal colorectal tissue in patients undergoing colorectal endoscopy or colorectal cancer surgery following a 14-day course of curcumin.

Secondary

* To assess the practicality, acceptability, and safety of administering 5 capsules of curcumin daily for 14 days.
* To check the presence of curcumin and its metabolites in peripheral blood and urine.

OUTLINE: Patients receive oral curcumin once daily for 14-28 days. Patients then undergo colorectal endoscopy or resection.

Normal colorectal tissue samples are collected via biopsy for curcumin assay after the last dose of curcumin. Patients also undergo blood and urine sample collection at baseline and after the last dose of curcumin for pharmacokinetic analysis by high performance liquid chromatography.

After completion of study treatment, patients are followed up at 14 days.

Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery

A Pilot Study of Administration of Curcumin to Determine Colonic Curcumin Tissue Levels in Patients Awaiting Colorectal Endoscopy or Patients With Colorectal Cancer Awaiting Resection

University of Leicester

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus	NCT00903136	Esophageal Canc... Precancerous Co...	questionnaire a... comparison of s... diagnostic endo... esophagogastrod... tethered capsul...	18 Years - 80 Years	National Cancer Institute (NCI)
Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients	NCT00899626	Colorectal Canc... Esophageal Canc... Gastric Cancer Pancreatic Canc... Precancerous Co...	protein analysi... proteomic profi... biologic sample... laboratory biom... medical chart r... diagnostic colo... diagnostic endo... diagnostic endo... diagnostic surg... endoscopic surg... screening colon...	18 Years -	Vanderbilt University Medical Center
Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus	NCT00987857	Esophageal Canc... Precancerous Co...	2 yearly endosc... comparison of s... diagnostic endo... endoscopic biop... endoscopic proc... quality-of-life... screening metho...	18 Years - 120 Years	Gloucestershire Hospitals NHS Foundation Trust
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus	NCT00903136	Esophageal Canc... Precancerous Co...	questionnaire a... comparison of s... diagnostic endo... esophagogastrod... tethered capsul...	18 Years - 80 Years	National Cancer Institute (NCI)
Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery	NCT00973869	Colorectal Canc...	curcumin high performanc... laboratory biom... pharmacological... diagnostic endo... therapeutic con...	18 Years -	National Cancer Institute (NCI)

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