NCT05483257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

July 29, 2022

Last Update Submit

July 31, 2022

Conditions

Keywords

human leukocyte antigen class Isupertypesrecurrence

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    Comparison of DFS between patients with specific HLA-I genotypes or not

    2 years

Interventions

HLA-I genotyping based on next-generation sequencing for prognosis evaluation

Eligibility Criteria

Age34 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Radically resected patients with pancreatic adenocarcinoma

You may qualify if:

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

You may not qualify if:

  • Pancreatic cancer except pancreatic adenocarcinoma
  • Non-radical resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Matched blood cells and tumor tissues

MeSH Terms

Conditions

Recurrence

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 2, 2022

Study Start

March 14, 2018

Primary Completion

August 3, 2020

Study Completion

September 13, 2021

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations