NCT06461598

Brief Summary

Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

January 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

June 11, 2024

Last Update Submit

June 11, 2024

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time between resection and death of any cause

    3-year

Study Arms (2)

Training cohort

Drug: Chemotherapy

Validation cohort

Drug: Chemotherapy

Interventions

ChemotherapyDRUG

All adjuvant chemotherapy for nonmetastatic PDAC was gemcitabine-based (Cycle \>= 1).

Training cohortValidation cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with incident, primary, microscopically-confirmed nonmetastatic PDAC who underwent resection were initially enrolled.

You may qualify if:

  • ECOG performance status score of 0-1 before resection
  • complete clinicopathologic and follow-up data
  • availability of formalin-fixed paraffin-embedded (FFPE) specimens of resected primary tumor and hematoxylin and eosin slides with invasive tumor components

You may not qualify if:

  • any previous history of cancer
  • any anticancer therapy prior to resection or adjuvant radiotherapy
  • metastatic cases
  • major postsurgical complications with Clavien-Dindo Grade ≥2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 17, 2024

Study Start

January 1, 2018

Primary Completion

March 16, 2020

Study Completion

May 31, 2021

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)