Integrative Proteomic Characterization of Pancreatic Duct... | NCT04525209

Studies
Integrative Proteomic Characterization of Pancreatic Ductal Adenocarcinoma

NCT04525209

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Aug 25, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Tumor Tissues and Non-tumor Tissues From PDAC Patients Were Used for Genomic and Transcriptome Sequencing Analysis and Proteomics and Phosphorylated Proteomics

Interventions

No intervention

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

Aug 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

Oct 1, 2020Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Aug 20, 2020

First Submission Date that Met QC Criteria

Aug 20, 2020

First Posted Date

Aug 25, 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

Aug 20, 2020

Last Update Posted Date

Aug 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

A large-scale, high-throughput, multi-dimensional comprehensive study of PDAC multiomics will be carried out. In this study, clinical specimens of resected PDAC collected by our research group from 2017 to 2019 will be selected as research objects.Tumor tissues and their adjacent non-tumor tissues from more than 200 PDAC patients are expected to be used for genome, transcriptome sequencing and mass spectrometry analysis of proteome and phosphorylated proteome.Combined with the data results of multiomics, bioinformatics analysis and network database information, we will clarify the relationship between multiomics of pancreatic cancer and established the new subtyping of pancreatic cancer proteome. A molecular landscape of the progression of pancreatic cancer at the genome-transcriptome-proteome level provides new therapeutic targets to improve the prognosis of this deadly disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Integrative Proteomic Characterization of PDAC	The genome-transcriptome proteome level provides a molecular landscape of the progression of pancreatic cancer, providing new therapeutic targets to improve the prognosis of PDAC	Two yeaers

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The diagnosis of pancreatic cancer was confirmed by histological examination or fine needle aspiration cytology;
The tumor was graded according to THE WHO standard, and the tumor stage was graded according to the TNM stage;

Exclusion Criteria:

The inclusion criteria of the above groups were not met;
There are few tissue specimens, only enough for clinical diagnosis;
Patients are unwilling to conduct follow-up study;
For the new diagnosed patient, radiotherapy or chemotherapy have been given in the previous three months;

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

Chinese PDAC patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hao Chen, MD	Contact	13003135899		haochendr@126.com
Lingxi Jiang, Ph.D	Contact	13818826142		jlx12120@rjh.com.cn

Overall Officials

Name	Affiliation	Role
Hao Chen, MD	Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RUIJIN Hospital		Shanghai	Shanghai Municipality	200025	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31585088	Background	Gao Q, Zhu H, Dong L, Shi W, Chen R, Song Z, Huang C, Li J, Dong X, Zhou Y, Liu Q, Ma L, Wang X, Zhou J, Liu Y, Boja E, Robles AI, Ma W, Wang P, Li Y, Ding L, Wen B, Zhang B, Rodriguez H, Gao D, Zhou H, Fan J. Integrated Proteogenomic Characterization of HBV-Related Hepatocellular Carcinoma. Cell. 2019 Oct 3;179(2):561-577.e22. doi: 10.1016/j.cell.2019.08.052.
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