Molecular Subtyping for Prognosis Evaluation in Resected... | NCT05483257

Studies
Molecular Subtyping for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma

NCT05483257

Sponsor

BAIYONG SHEN

Status

Completed

Last Update Posted

Aug 2, 2022Actual

Enrollment

226Actual

Phase

Not provided

Conditions

Pancreatic Cancer Resectable

Interventions

Multigene panel for next-generation sequencing

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2018Actual

Primary Completion Date

Aug 3, 2020Actual

Completion Date

Sep 13, 2021Actual

First Submitted Date

Jul 29, 2022

First Submission Date that Met QC Criteria

Jul 31, 2022

First Posted Date

Aug 2, 2022Actual

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

Jul 31, 2022

Last Update Posted Date

Aug 2, 2022Actual

Name	Class
GeneCast Biotechnology Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Pancreatic adenocarcinoma (PAAD) patients following surgeries are prone to relapse shortly, while it is not well understood by current biomarkers. Given the potential associations of human leukocyte antigen class I (HLA-I) genotype with oncogenic mutational profile and immunotherapy efficacy, we aimed to assess whether differential HLA-I genotype could predict the postoperative outcomes in resected PAAD patients.

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

226Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multigene panel for next-generation sequencing	Device	HLA-I genotyping based on next-generation sequencing for prognosis evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free survival (DFS)	Comparison of DFS between patients with specific HLA-I genotypes or not	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radically resected pancreatic adenocarcinoma (stage I-III)
Resected tumor tissues and matched blood cells available
Signed informed consent

Exclusion Criteria:

Pancreatic cancer except pancreatic adenocarcinoma
Non-radical resection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

34 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Radically resected patients with pancreatic adenocarcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37026827	Derived	Wen C, Zhang L, Yang Y, Jin Y, Ren D, Zhang Z, Zou S, Li F, Sun H, Jin J, Lu X, Xie J, Cheng D, Xu Z, Chen H, Mao B, Zhang J, Wang J, Deng X, Peng C, Li H, Jiang C, Lin L, Zhang H, Chen H, Shen B, Zhan Q. Specific human leukocyte antigen class I genotypes predict prognosis in resected pancreatic adenocarcinoma: a retrospective cohort study. Int J Surg. 2023 Jul 1;109(7):1941-1952. doi: 10.1097/JS9.0000000000000264.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D017421	Sequence Analysis
D005821	Genetic Techniques
D008919	Investigative Techniques