Clinical trial · Observational
Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON)
Biobanking Upper Gastrointestinal Tumors to Evaluate Response With Additional Banking of Cutaneous Neoplasms (BURGER With BACON)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study abandoned and not opening for recruitment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GastroEsophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune checkpoint inhibitor (ICI) or chemotherapy alone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort A
- description
- Participating subjects will be enrolled prior to initiating treatment with a regimen that includes an immune checkpoint inhibitor or chemotherapy alone in the case of the immunotherapy ineligible cohort. Archived formalin fixed paraffin embedded (FFPE) tumor tissue will be collected for all subjects if available. Patients will have an optional fresh research only biopsy if there is a lesion amenable to safe biopsy which will be frozen for further studies.
- interventionNames
- Drug: Immune checkpoint inhibitor (ICI) or chemotherapy alone
- label
- Cohort B (Melanoma Cohort)
- description
- Melanoma samples were previously collected and analyzed under Pro00059349, NCT02694965. Data will continue to be collected from participant's electronic medical records.
- interventionNames
- Drug: Immune checkpoint inhibitor (ICI) or chemotherapy alone
- label
- Cohort C
- description
- Retrospective portion that will allow for collection of data and archived tissue The Duke Enterprise Data Unified Content Explorer (DEDUCE) software tool will be utilized to identify patients with gastroesophageal adenocarcinoma or squamous cell or melanoma initiated on anti-PD-1 antibody immunotherapy at Duke University Medical Center and the Duke Cancer Institute between January 1, 2011 and August 31, 2023, and patients ineligible for immunotherapy that received chemotherapy during the same time period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Cohort A (GE Cohort) For this study, a maximum of 40 evaluable patients with gastroesophageal adenocarcinoma and 20 patients with squamous cell carcinoma who will receive anti-PD-1 treatment as standard of care treatment will be enrolled (combination therapy regimen with other agents are allowed). Evaluable patients are those that have received at least one dose of anti-PD-1 treatment. 10 patients who are ineligible for immunotherapy will also be enrolled to meet the exploratory objective. Inclusion Criteria: 1. Age \> 18 years 2. Ability to understand and the willingness to sign a written informed consent document 3. Diagnosis of gastric, esophageal, or gastroesophageal junction adenocarcinoma or squamous cell carcinoma. 4. Available archival tumor tissue or willingness to undergo research biopsy. Exclusion Criteria: 1. Patients unable to comply with the requirements of the study protocol 2. Patients known to be pregnant or nursing 3. Serious pre-existing medical condition, that in the opinion of the investigator, makes the patient unsuitable for the study Cohort B (Melanoma Cohort) 1\. 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 1. 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. 2. Melanoma subjects in cohort C must have stage II, III, or IV disease validated by histology or cytology 1. Primary cutaneous melanomas or melanomas of unknown primary site are eligible 2. Melanoma subjects must have been treated with immunotherapy (combination with other agents not allowed) 3. Patients with intra-cranial disease or disease involving the central nervous system are eligible.
References
Publications (0)
Data not yet available