GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

NCT ID: NCT05644431

Last Updated: 2023-08-30

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

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-19

Study Completion Date

2028-01-15

Brief Summary

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This trial is a prospective, monocentric, non-therapeutic, interventional cohort study aiming to decipher the immune TME through standard neoadjuvant CT in resectable G/GEJ adenocarcinomas. This study will also longitudinally monitor MRD during neoadjuvant and adjuvant therapy.

Detailed Description

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Conditions

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GastroEsophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric and gastroesophageal junctional adenocarcinomas

Patient under standard chemotherapy in localized and resectable gastric and gastroesophageal junctional adenocarcinomas

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female patient \> 18 years of age on day of signing informed consent.
* Histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III to be treated with standard neoadjuvant treatment.
* Surgery of primary tumor to be done at Centre Léon Bérard.
* Availability of archival FFPE tumor block from initial diagnosis with at least 20% of tumor cells.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
* Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
* Patients must be covered by a medical insurance.

Exclusion Criteria

* Any condition contraindicated with blood sampling procedures required by the protocol.
* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer
* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
* Pregnant or breast-feeding woman.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Leon Berard

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clélia COUTZAC, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

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Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Clélia COUTZAC, MD

Role: CONTACT

04 78 78 60 20

Facility Contacts

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Clélia COUTZAC, MD

Role: primary

04 78 78 60 20

Other Identifiers

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ET22-201

Identifier Type: -

Identifier Source: org_study_id

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