Molecular Taxonomy of Surgically-harvested Ocular Tissues... | NCT04682054

Studies
Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics

NCT04682054

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Unknown status

Last Update Posted

Dec 23, 2020Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Diabetic Retinopathy
Proliferative Vitreoretinopathy
Pterygium
Glaucoma

Interventions

ocular surgery

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2021Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Dec 7, 2020

First Submission Date that Met QC Criteria

Dec 20, 2020

First Posted Date

Dec 23, 2020Actual

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

Dec 20, 2020

Last Update Posted Date

Dec 23, 2020Actual

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 surgically-harvested eye tissue (ie. vitreous-retinal proliferative membrane, outflow pathway, retinas, and pterygium) is a complex tissue responsible for maintaining intraocular homeostasis or mediating ocular pathogenesis. Dysfunction of one or more resident cell types within the tissues results in different ocular disorder, leading to vision loss, or even blindness. In this study, we aim to use single-cell RNA sequencing to generate a comprehensive cell atlas of surgically-harvested eye tissues.

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgically-removed eye tissue	Experimental		Procedure: ocular surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ocular surgery	Procedure	surgery to remove the pathological eye tissue	surgically-removed eye tissue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
counts of each cell type	single-cell sequencing identify what cells and the counts within the eye tissue	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ocular diseases and require surgery intervention.
The surgery intervention remove pathological tissue during surgery.
Patients consent to the treatment and single-cell sequencing.

Exclusion Criteria:

1. Surgically removed eye tissue cannot meet with the quality control of single-cell sequencing (mainly the tissue weight and cell counts);

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zizong Hu, PhD, MD	Contact	+8615195960100		huzizhong@njum.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Nanjing Medical University		Nanjing	Jiangsu	210029	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33221324	Background	Tan WJ, Wang MM, Castagnoli PR, Tang T, Chan ASY, Lim TS. Single B-Cell Genomic Analyses Differentiate Vitreoretinal Lymphoma from Chronic Inflammation. Ophthalmology. 2021 Jul;128(7):1079-1090. doi: 10.1016/j.ophtha.2020.11.018. Epub 2020 Nov 20.
33161127	Background	Wynne N, Carroll J, Duncan JL. Promises and pitfalls of evaluating photoreceptor-based retinal disease with adaptive optics scanning light ophthalmoscopy (AOSLO). Prog Retin Eye Res. 2021 Jul;83:100920. doi: 10.1016/j.preteyeres.2020.100920. Epub 2020 Nov 6.

ID	Term
D003930	Diabetic Retinopathy
D018630	Vitreoretinopathy, Proliferative
D011625	Pterygium
D005901	Glaucoma

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases