Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer

NCT06877910 | Active Not Recruiting

• 1 other identifier: RS1377/20(2378)
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC.

Conditions

Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival PFS

  PFS will be defined as the time from the start of first-line chemotherapy to disease progression or death

  5 years

Secondary Outcomes (1)

• Overall survival OS

  5 years

Study Arms (2)

Retrospective, identification set

A workflow based on numerous statistical analyses will assign the individual molecular outcomes in one of the three categories considered (exceptional responders, conventional responders, fast progressors). The information retrieved with this first level of analysis will be summarized in a single tool for the prediction of individual risk (nomogram). In order to guarantee reproducibility, the prognostic classifier will be obtained from a retrospective cohort of patients with mGC treated with standard first-line chemotherapy.

Prospective, validation set

Definition of the evolutionary trajectories of atypical responders mGC, by taking blood samples from patients enrolled in the prospective cohort, collected at predefined time points. The serial collection of blood samples will allow the study of circulating nucleic acids (cfTNA, liquid biopsy) for the monitoring of genomic alterations and for the levels of gene expression differentially represented in exceptional responders and fast progressors.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced or metastatic inoperable GC who are candidates for first-line chemotherapy and who meet the following criteria.

You may qualify if:

• Age \>18 years;
• Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC);
• Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
• ECOG PS 0-2;
• Adequate hematological, hepatic and renal function;
• Measurable disease according to RECIST criteria;
• Written informed consent.

You may not qualify if:

• Previous chemotherapy for metastatic disease;
• Comorbidities not controlled with adequate medical therapy;
• Brain metastases;
• Patient unable to give adequate consent to the study.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

IRCCS National Cancer institute

Rome, 00144, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: January 10, 2021
• Primary Completion: June 20, 2023
• Study Completion: January 10, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

IT (1)