Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON)
Withdrawn before enrolling
Conditions studied: GastroEsophageal Cancer
In brief
The goal of this observational study is to examine genetic changes that may contribute to immunotherapy resistance in gastroesophageal cancer. This information can potentially lead to the identification of new immunotherapeutic targets as well as improve the ability to identify those patients more likely to respond to immunotherapy. This study does not include any treatment or investigational drugs. Participants will be asked: * to enroll before beginning standard care of treatment for their cancer * for blood, archived tumor tissue, and fresh tumor tissue Researchers will compare participants who are not getting immunotherapy to identify potential differences in expression levels of a gene.
Key facts
- Study ID
- NCT06283238
- Run by
- Duke University
- People needed
- 0
- Starts
- 2025-04-16
- Expected to finish
- 2027-03-25
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years
- Ability to understand and the willingness to sign a written informed consent document
- Diagnosis of gastric, esophageal, or gastroesophageal junction adenocarcinoma or squamous cell carcinoma.
- Available archival tumor tissue or willingness to undergo research biopsy.
You may not qualify if…
- Patients unable to comply with the requirements of the study protocol
- Patients known to be pregnant or nursing
- Serious pre-existing medical condition, that in the opinion of the investigator, makes the patient unsuitable for the study
- Cohort B (Melanoma Cohort)
- All subjects that consented and enrolled to Pro00059349 will be rolled into this protocol for specimen analysis. See Pro00059349 for eligibility criteria for those subjects.
- Cohort C (Retrospective Cohort) Eligibility Criteria
- GE subjects must have been treated with an immune checkpoint inhibitor for gastroesophageal adenocarcinoma or squamous cell carcinoma, or have been ineligible for immunotherapy due to low PD-L1 and received chemotherapy.
- Melanoma subjects in cohort C must have stage II, III, or IV disease validated by histology or cytology
- Primary cutaneous melanomas or melanomas of unknown primary site are eligible
- Melanoma subjects must have been treated with immunotherapy (combination with other agents not allowed)
- Patients with intra-cranial disease or disease involving the central nervous system are eligible.
Where it is running
- Duke University — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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