NCT05644431 GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
| NCT ID | NCT05644431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Leon Berard |
| Condition | GastroEsophageal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-07-19 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-07-19 with a primary completion date of 2028-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Clélia COUTZAC, MD
PRINCIPAL INVESTIGATOR
Centre Leon Berard
Frequently Asked Questions
Who can join the NCT05644431 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying GastroEsophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05644431 currently recruiting?
Yes, NCT05644431 is actively recruiting participants. Contact the research team at clelia.coutzac@lyon.unicancer.fr for enrollment information.
Where is the NCT05644431 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT05644431 clinical trial?
NCT05644431 is sponsored by Centre Leon Berard. The principal investigator is Clélia COUTZAC, MD at Centre Leon Berard. The trial plans to enroll 50 participants.
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