NCT04842916

Brief Summary

Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
3 countries

5 active sites

Status
recruiting

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 Progress84%
Sep 2020May 2027

Study Start

First participant enrolled

September 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2027

Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

6.7 years

First QC Date

December 23, 2020

Last Update Submit

November 19, 2024

Conditions

Gastric Cancer

Keywords

Gastric cancer, Chemotherapy, Response, Personalized medicine

Outcome Measures

Primary Outcomes (5)

  • Genomic alterations in tumoral tissue in responders and non-responders

    Number of Genomic alterations in tumoral tissue

    36 months

  • Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders

    Analysis of type and size of immune cell subpopulations surrounding primary tumor and extracellular matrix composition on FFPE samples collected at diagnosis and/or surgery. Correlation of data acquired to Participant's response score (TRG or DFS).

    36 months

  • Analysis of cell-free DNA (cfDNA) from blood samples in responders and non-responders

    cfDNA will be quantified in Participant's peripheral blood derivatives (plasma, serum) and characterized for Genomic alterations. Samples will be obtained (1) prior to and (2) by completion of chemotherapy in the Neoadjuvant Chemotherapy (NCT) treated cohorts, together with sampling after surgery (3). TRG score will be utilized as measure of response. Accordingly, in NCT-naive cohorts, analysis of samples obtained 1) pre- operatively and 2) by completion of post-operative chemotherapy treatment will be correlated with the respective Disease-Progression clinical indicators.

    36 months

  • Analysis of circulating tumor cells (CTC) from blood samples in responders and non-responders.

    gene expression profile of CTC cells (when isolated in sufficient quantity)

    36 months

  • Peripheral blood mononuclear cells (PBMCs) and host immunity parameters in responders and non-responders

    Phenotype analysis of representative immune cell subpopulations (i.e. monocytes, helper T cells, cytotoxic T cells, Tregs, Natural Killer (NK) /NKT) in Participants' peripheral blood samples obtained prior- and post- treatment. Combinational analysis of data acquired in correlation with Patient's response score.

    36 months

Secondary Outcomes (1)

  • Psychological status of patients in relation to therapy response

    36 months

Study Arms (1)

Gastric cancer patients

gastric cancer patients with histologically confirmed, potentially resectable adenocarcinoma of the stomach or the gastroesophageal junction receiving the standard of medical care in Europe

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) who received pre- or peri-operative chemotherapy or up-front surgery followed by chemotherapy

You may qualify if:

  • Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +/- Docetaxel)
  • Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable
  • Male or Female, aged \>18 years
  • Availability of tissue samples and clinico-pathological data for retrospective cohort

You may not qualify if:

  • Age \< 18 years
  • Early Gastric Cancer and T2 (if N0)
  • Linitis plastica
  • Positive peritoneal cytology or peritoneal involvement
  • Distant metastases
  • Patient refusal to participate
  • Patient refusal to the use of their own samples for research
  • Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling
  • Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable
  • Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier Regional et Universitaire (CHRU)

Brest, 29200, France

NOT YET RECRUITING

INSERM, Faculty of Medicine (UMR1078)

Brest, 29200, France

ACTIVE NOT RECRUITING

1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)

Athens, 11527, Greece

NOT YET RECRUITING

IRST IRCCS UO Oncologia

Meldola, 47014, Italy

RECRUITING

AUSL Romagna, UO Oncologia

Ravenna, 48121, Italy

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Formalin Fixed Paraffin Embedded (FFPE) tissue, Blood, Fresh Frozen (FF) tissue

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Chiara Molinari

    IRST IRCCS

    STUDY CHAIR

Central Study Contacts

Chiara Molinari

CONTACT

chiara.molinari@irst.emr.it

Chiara Zingaretti

CONTACT

cc.ubsc@irst.emr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2020

First Posted

April 13, 2021

Study Start

September 22, 2020

Primary Completion (Estimated)

May 22, 2027

Study Completion (Estimated)

May 22, 2027

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

GR(1)IT(2)FR(2)