Molecular Subtyping for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma

Sponsor

BAIYONG SHEN (Other)

Overall Status

Completed

CT.gov ID

NCT05483257

Collaborator

GeneCast Biotechnology Co., Ltd. (Industry)

226

Enrollment

Location

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Resectable	Device: Multigene panel for next-generation sequencing

Study Design

Study Type:

Observational

Actual Enrollment :

226 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Molecular Subtyping Based on Specific HLA-I Genotypes for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma: A Retrospective Observational Cohort Study

Actual Study Start Date :

Mar 14, 2018

Actual Primary Completion Date :

Aug 3, 2020

Actual Study Completion Date :

Sep 13, 2021

Outcome Measures

Primary Outcome Measures

Disease-free survival (DFS) [2 years]
Comparison of DFS between patients with specific HLA-I genotypes or not

Eligibility Criteria

Criteria

Ages Eligible for Study:

34 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

BAIYONG SHEN
GeneCast Biotechnology Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BAIYONG SHEN, Professor, Ruijin Hospital

ClinicalTrials.gov Identifier:

NCT05483257

Other Study ID Numbers:

M-Cli200633-PC

First Posted:

Aug 2, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by BAIYONG SHEN, Professor, Ruijin Hospital

human leukocyte antigen class I

supertypes

recurrence

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Aug 2, 2022