Signature for Precise Chemosensitivity Prediction in PDAC

NCT ID: NCT06461598

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training cohort

Chemotherapy

Intervention Type DRUG

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

Validation cohort

Chemotherapy

Intervention Type DRUG

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

Interventions

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Chemotherapy

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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lei huang

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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ChemoResist-01

Identifier Type: -

Identifier Source: org_study_id

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