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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05483257
Other study ID # M-Cli200633-PC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 14, 2018
Est. completion date September 13, 2021

Study information

Verified date July 2022
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 226
Est. completion date September 13, 2021
Est. primary completion date August 3, 2020
Accepts healthy volunteers No
Gender All
Age group 34 Years to 84 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Multigene panel for next-generation sequencing
HLA-I genotyping based on next-generation sequencing for prognosis evaluation

Locations

Country Name City State
China Ruijin Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
BAIYONG SHEN GeneCast Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free survival (DFS) Comparison of DFS between patients with specific HLA-I genotypes or not 2 years
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