Early Detection of Head and Neck Superficial Squamous Cel... | NCT03700398

Studies
Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma

NCT03700398

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Oct 9, 2018Actual

Enrollment

214Estimated

Phase

Not Applicable

Conditions

Optical Enhancement Endoscopy

Interventions

first OE
first WLI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Jan 1, 2019Estimated

Completion Date

Feb 1, 2019Estimated

First Submitted Date

Sep 23, 2018

First Submission Date that Met QC Criteria

Oct 6, 2018

First Posted Date

Oct 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2018

Last Update Posted Date

Oct 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. objects in this group will first receive WLI observation and subsequent OE observation during oropharynx and hypopharynx. Then, the investigators will compare the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma of two groups to find if OE endoscopy can improve the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma in esophageal cancer patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

214Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
first OE	Experimental		Device: first OE
First WLI	Other		Device: first WLI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
first OE	Device	optical enhancement(OE)，a kind of electron straining endoscopy	first OE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detect rate	the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

order than 18 years old
Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma

Exclusion Criteria:

Previously confirmed pharynx/oropharyngeal squamous cell carcinoma
Advanced pharynx/hypopharyngeal squamous cell carcinoma
Pregnant women and lactating women
pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis
Previous chemotherapy or radiation therapy affected observation
Not completed gastroscopy or refused to take biopsy for various reasons
Mental illnesses such as anxiety and depression affect the endoscopic observation
Severe systemic disease, can not tolerate gastroscopy
Refusal to sign informed consent books

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital of Shandong University	Recruiting	Jinan	Shandong		China