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Signature for Precise Chemosensitivity Prediction in PDAC

Development and Validation of the ChemoResist Signature Precisely Predictive of Chemotherapy Sensitivity in Resected Pancreatic Ductal Adenocarcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06461598
Enrollment
365
Registered
2024-06-17
Start date
2018-01-01
Completion date
2021-05-31
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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.

Interventions

DRUGChemotherapy

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

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival3-yearTime between resection and death of any cause

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026