NCT03700398

Unknown

Early Detection of Head and Neck Superficial Squamous Cell C...

Shandong University Source

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Other study identifiers

Sponsor study identifier

2017SDU-QILU-06

Study Type

interventional

Estimated enrollment

214

Locations

1 country

Sites

1

Timeline

Study Start

October 1, 2017

Actual (reported)

Primary Completion

January 1, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

February 1, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 214 participants
Study completion date: February 1, 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 1, 2017
Actual (reported)
First Submitted
September 23, 2018
Actual (reported)
First Posted
October 9, 2018
Actual (reported)
Primary Completion
January 1, 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2019
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: October 9, 2018
Status Verified: October 2018
Last Update Submitted: October 6, 2018

Conditions

Optical Enhancement Endoscopy

Outcome Measures

Primary Outcomes (1)

detect rate
the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma
12 months

Study Arms (2)

first OE

EXPERIMENTAL

Device: first OE

First WLI

OTHER

Device: first WLI

Interventions

first OEDevice

optical enhancement(OE)，a kind of electron straining endoscopy

first OE

first WLIDevice

the routine in the clinical practice

First WLI

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Shandong University
Otherlead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Yanqing Li, PHDCONTACT86-531-82169236 liyanqing@sdu.edu.cn

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: vice president of Qilu Hospital

Study Record Dates

First Submitted

September 23, 2018

First Posted

October 9, 2018

Study Start

October 1, 2017

Actual (reported)

Primary Completion

January 1, 2019

Estimated (date passed)

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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

February 1, 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

October 9, 2018

Record last verified: 2018-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03700398
Data provider: ClinicalTrials.gov
Source updated: 2018-10-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:04 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

first OE

First WLI

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

Source record

Locations